SURVEILLANCE

FOR DIPHTHERIA,
PERTUSSIS AND
NEONATAL TETANUS

India I Field Guide

SURVEILLANCE
FOR DIPHTHERIA,
PERTUSSIS AND
NEONATAL TETANUS
India I Field Guide

FIRST EDITION 2020

Ministry of Health and Family Welfare

Government of India
CONTENTS
Acknowledgement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . i
Acronyms and Abbreviations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

PATHOGEN AND DISEASE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Diphtheria: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Pertussis: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Neonatal Tetanus:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

LABORATORY DIAGNOSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Diphtheria:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Pertussis: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Neonatal Tetanus: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

IMMUNIZATION AND IMMUNE RESPONSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Components of DPT-containing vaccines (pentavalent, DPT, Td): . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

CASE SELECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Diphtheria: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Pertussis:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Neonatal Tetanus: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

CASE INVESTIGATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Description of case investigation form: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

ASSIGNING A UNIQUE IDENTIFICATION CODE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

SAMPLE COLLECTION AND TRANSPORTATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Procedures for collecting samples:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

CASE CLASSIFICATION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21

CASE MANAGEMENT AND PUBLIC HEALTH INTERVENTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Diphtheria: Case Management: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Pertussis: Case Management: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Neonatal Tetanus: Case Management:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Active Case Search, Contact Tracing and Management: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Diphtheria: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Pertussis: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Neonatal tetanus: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
MONITORING AND SUPERVISION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Monitoring indicators: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Data Analysis: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Active supervision:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Making supervision more effective:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Dissemination of surveillance data: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

REPORTING NETWORK AND CASE NOTIFICATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Structure: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Functions: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Collaboration and sensitization of health facilities:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

ROLES AND RESPONSIBILITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Implementing authority:. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45
Technical advice and capacity building: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Monitoring and Evaluation: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
Public health interventions and system strengthening: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

ANNEXURES
Annexure 1: Case investigation form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Annexure 2: VPD-ACS DTH/PTS form . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Annexure 3: VPD-ACS NT form. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
Annexure 4: Diphtheria antitoxin (DAT) administration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
Annexure 5: Surveillance forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Annexure 6: Supportive supervision form – VPD surveillance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
Annexure 7: Vaccine preventable disease (VPD) surveillance during the COVID-19 pandemic . . . . . . . . . . . . 59
References: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63
ACKNOWLEDGEMENT
Diphtheria, pertussis and neonatal tetanus surveillance operational guideline has been prepared in
consultation with WHO National Public Health Surveillance Project (NPSP).

Advisors:
Ms Vandana Gurnani, Joint Secretary, Ministry of Health and Family Welfare, Government of India
Dr Manohar Agnani, Joint Secretary, Ministry of Health and Family Welfare, Government of India
Dr Pradeep Haldar, Deputy Commissioner (UIP), Ministry of Health and Family Welfare, Government of India
Dr M K Aggarwal, Joint Commissioner, Ministry of Health and Family Welfare, Government of India
Dr Sunil Bahl, WHO South-East Asia Regional Ofce
Dr Pauline Harvey, WHO Country Ofce for India
Dr Pankaj Bhatnagar, WHO Country Ofce for India

Authors:
Dr Sudhir Joshi, WHO South-East Asia Regional Ofce
Dr Lucky Sangal, WHO Country Ofce for India
Dr Arun Kumar, WHO Country Ofce for India

Support in reviewing the manuscript:

CDC: Christopher S Murril; Kristie E. N. Clarke; Maria L Tondella; Tejpratap Tiwari
Immunization Technical Support Unit: Dr Prem Singh
MoHFW: Dr Disha Agarwal, Dr Ashish Kumar
WHO Country Ofce for India: Dr Kristin VanderEnde, Dr Preeti Nigam, Dr Rachana Kathuria, Dr Danish
Ahmed, Dr Mandeep Rathee, Dr Sachin Rewaria

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ACRONYMS AND ABBREVIATIONS
ACS active case search
AFP acute accid paralysis
aP acellular pertussis (vaccine)
ATS antitoxin tetanus serum
BCG Bacillus Calmette-Guérin
CFR case fatality rate/ratio
CIF case investigation form
CMO Chief Medical Ofcer
COVID-19 Coronavirus Disease 2019
DAT diphtheria antitoxin
DIO District Immunization Ofcer
DNA deoxyribonucleic acid
DPT diphtheria, pertussis and tetanus
EPI Expanded Programme on Immunization
Hib Haemophilus inuenzae type b
IgG immunoglobulin G
IPC infection prevention and control
IPV inactivated polio vaccine
IU informer unit
IVIG intravenous immunoglobulin
JE Japanese encephalitis
JRF Joint Reporting Form
M&E monitoring and evaluation
MHA Ministry of Home Affairs
MO medical ofcer
MOIC medical ofcer in-charge
MR measles–rubella
NPSP National Public Health Surveillance Project
NT neonatal tetanus
OPV oral polio vaccine
PCR polymerase chain reaction

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PEP post-exposure prophylaxis
PPE Personal protective equipment
RI routine immunization
RU reporting unit
SMO Surveillance Medical Ofcer
TB tuberculosis
Td tetanus–diphtheria (vaccine)
TIG tetanus immune globulin
TT tetanus toxoid
UIP Universal Immunization Programme
UNICEF United Nations Children’s Fund
VPD vaccine-preventable disease
WHO World Health Organization
wP whole cell pertussis (vaccine)

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INTRODUCTION
Vaccination against childhood communicable diseases through the Expanded Programme on
Immunization (EPI) is one of the most cost-effective public health interventions. Vaccination
contributes substantially to the achievement of Sustainable Development Goals (SDGs) by reducing
mortality and morbidity among children. The progress and impact of vaccination programmes can be
effectively assessed by surveillance for vaccine preventable diseases (VPDs). It is also important to
have country-specic epidemiological data to be able to formulate vaccination strategies.

Surveillance is the basic tool for understanding the epidemiology of a disease. The key objectives of
surveillance are to trigger public health control measures, identify outbreaks and assess the
effectiveness of prevention programmes. The burden and epidemiology of VPDs may vary by country
because of differences in immunization coverage, nutritional status, population density, geo-
sociocultural diversity, environmental factors and possibly, genetic differences in populations.
Therefore, establishing an active surveillance system is essential to monitor an area more closely and
directly in order to generate reliable surveillance data of programmatic importance.

The pentavalent vaccine which provides protection from ve diseases including diphtheria, pertussis
and tetanus forms the backbone of the current EPI schedule. Many of the newer vaccines are provided
either in combination with or during the same visit as for DPT containing vaccine. Hence, surveillance
for at least three VPDs – notably diphtheria, pertussis and neonatal tetanus (NT), together with
poliomyelitis, measles and rubella will provide important information on the status of control of these
diseases and on the overall performance of the immunization programme. Further, it will also help in
identifying pockets of susceptible individuals to guide vaccination strategies.

Following an increase in incidence of pertussis in a few countries using acellular pertussis (aP)
vaccines, and concern about the potential for global resurgence of pertussis, a review was conducted
by World Health Organization (WHO) in 2014. Overall, data from 19 high- and middle-income countries
provided no evidence of a widespread resurgence of pertussis. In most countries where increasing
numbers of pertussis cases were noted over several recent years, it was mainly attributed to naturally
occurring cyclic patterns. Factors that have probably contributed to the increasing numbers of
recorded cases include higher disease awareness, improved surveillance sensitivity and the enhanced
diagnostic sensitivity of the now widely used polymerase chain reaction (PCR) test. However, there is
evidence that a true resurgence has occurred in ve of the 19 countries reviewed, four of which were
exclusively using aP vaccines. The observed increase in cases in the fth country, which used whole-
cell pertussis (wP) vaccine, was considered to be primarily related to factors other than the vaccine,
such as changes in surveillance and laboratory methods and recent decreases in vaccination coverage
(1,2). India has been using wP vaccine since the beginning of EPI in the country in 1978.

In India, the availability of quality surveillance data for VPDs is limited. WHO disease burden estimates
are based on information available from a variety of sources such as demographic data, immunization
coverage levels, vital registration data, mortality data and mathematical models using numerous

1
assumptions. The degree of accuracy of these estimates depends upon the quality of surveillance data
available in the country. In 2018, India reported 8788 cases of diphtheria, 13 208 cases of pertussis
and 129 cases of NT to WHO and United Nations Children’s Fund (UNICEF) through the Joint Reporting
Form (JRF). However, the quality and completeness of these reports is not known.

This manual describes various operational strategies for strengthening surveillance for diphtheria,
pertussis and NT, building on the already existing acute accid paralysis (AFP) surveillance system,
with the objective of generating reliable epidemiological information about the above mentioned
diseases. It also focusses on key components of monitoring and evaluation plans necessary for
maintaining an effective and efcient surveillance and response system. This eld guide is designed
primarily for the district health ofcials of government and implementing partners. The WHO National
Public Health Surveillance Project (NPSP) eld units will provide technical support for establishing a
functional laboratory-supported surveillance system for VPDs. Their primary functions will be
capacity-building of health-care providers/surveillance staff, monitoring and evaluation of the key
components of surveillance, data analysis and providing feedback. The information generated will be
used locally to guide control measures and strengthen the evolving surveillance system.

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PATHOGEN AND DISEASE
Diphtheria
Diphtheria is derived from the Greek word diphthera meaning “skin” or “hide”, which describes the
pathognomonic pseudo-membrane associated with the disease.

Aetiopathogenesis
Diphtheria is a bacterial disease caused by exotoxin producing Corynebacterium diphtheriae.
C. diphtheriae is a slender, club-shaped, gram positive bacillus that exists in four biotypes (gravis,
mitis, belfanti and intermedius). Rarely, other Corynebacterium species (C. ulcerans or C.
pseudotuberculosis) may produce diphtheria toxin and may cause classic respiratory diphtheria-
like illness.

The pathogenesis of diphtheria involves bacterial exotoxin as well as cell wall components such as the
O- and K- antigens. The most important virulence factor of C. diphtheriae is the exotoxin, a
bacteriophage mediated, highly conserved polypeptide encoded by the bacterial chromosome.
Outside the host cell, the exotoxin is relatively inactive, but following cellular attachment and
internalization by its non-toxic fragment B, a highly toxic fragment (A) is detached that kills cells through
inhibition of cellular protein synthesis. Diphtheria exotoxin causes both local and systemic cell
destruction (3).

Transmission and communicability

Transmission is most often person-to-person spread from the respiratory tract through droplets or
direct contact with respiratory secretions. Rarely, transmission may occur from skin lesions or articles
soiled with discharges from lesions of infected persons (fomites). The incubation period of diphtheria is
2–5 days (range 1–10 days).

A person is infectious as long as virulent bacilli are present in discharges and lesions. The period of
infectivity is variable, but organisms usually persist for two weeks, and seldom more than six weeks
without antibiotics. Chronic carriers may shed organisms for six months or more. Effective antibiotic
therapy promptly terminates shedding (3).

Reservoir
Humans are the only known reservoir of C. diphtheriae. In most cases, transmission of C. diphtheriae
to susceptible individuals results in transient pharyngeal carriage rather than in disease. During
outbreaks, high percentages of children are found to be transient carriers.

Occurrence
The disease has almost disappeared from developed countries as a result of high immunization
coverage. Continued foci of epidemicity and endemicity exist in some parts of the world with low
immunization coverage, including the Indian subcontinent and South East Asia.

Clinical features and complications

Most infections are asymptomatic or run a relatively mild clinical course. The onset of respiratory

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diphtheria is relatively slow and is characterized by moderate fever and a mild exudative pharyngitis
leading to sore throat and difculty in swallowing. The exudate organizes into a tough, asymmetric,
greyish-white pseudo-membrane over the tonsils, the pharynx, larynx and/or nose. The pseudo-
membranes are strongly attached to the underlying tissue and attempts to dislodge it usually result in
bleeding. They may extend into the nasal cavity and the larynx, causing obstruction of the airways.
Laryngeal diphtheria, which sometimes occurs even without pharyngeal involvement, is a medical
emergency that often requires tracheostomy. Accompanying inammation of the cervical lymph nodes
and surrounding soft-tissue swelling of the neck give rise to a “bull neck” appearance and are signs of
moderate to severe disease.

Exotoxin absorbed from the mucosal (or cutaneous) lesions may account for toxic damage to organs
such as the myocardium, kidneys and nervous system. The extent of toxin absorption depends largely
on the extent of the mucosal lesions. The following WHO-dened clinical conditions are associated
with increasing risk of toxin-induced systemic disease:
• Catarrhal: erythema of pharynx, no membranes
• Follicular: patches of exudates over pharynx and the tonsils
• Spreading: membranes covering the tonsils and posterior pharynx
• Combined: more than one anatomical site involved, e.g. throat and skin.

Most complications of diphtheria, including death, are attributable to effects of the toxin. The most
frequent complications of diphtheria are myocarditis and neuritis. Neuritis may lead to bulbar
dysfunction (which includes palatal, pharyngeal and facial paralysis), oculomotor paralysis and may
also progress to peripheral neuropathy. Pneumonia occurs in more than 50% of fatal cases of
diphtheria. Other complications include otitis media and respiratory insufciency due to airway
obstruction, especially in infants.

Prognosis
Most cases of diphtheria develop in non-immunized patients. The attack rate, severity of disease and
risk of complications are much lower in immunized patients. Mortality increases with the severity of
local disease, the extent of pseudo-membrane formation and delay between onset of local disease and
administration of antitoxin. The death rate is highest during the rst week of illness among patients with
bull neck, myocarditis and laryngeal or tracheo-bronchial involvement. The case fatality rate (CFR)
from respiratory tract diphtheria has been 2–20% with an average of 10% for patients receiving good
medical care.

Pertussis
Pertussis is an acute infectious disease of the respiratory tract. It is commonly known as whooping
cough. The name pertussis means “violent cough”, which aptly describes the most consistent and
prominent feature of the illness.

Aetiopathogenesis
Pertussis is a bacterial disease caused by Bordetella pertussis. Bordetella spp. are aerobic, gram
negative coccobacilli. In addition to B. pertussis, three other Bordetella species can cause disease in

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humans: B. parapertussis, B. holmesii and B. bronchiseptica. B. parapertussis causes a milder
pertussis-like illness. Coinfection of B. pertussis and B. parapertussis is not unusual.

The pathogenesis of pertussis is incompletely understood. It is multifactorial. The factors like

lamentous haemagglutinin, pertactin and mbriae type 2 and type 3 facilitate attachment to targeted
host cells. Other factors like pertussis toxin, tracheal cytotoxin and adenylate cyclase toxin enable the
bacterium to destroy the epithelial lining and evade the host’s immune system (1).

Transmission and communicability

B. pertussis is a human-specic pathogen and is unable to survive outside its human host. It is highly
infectious and spreads by aerosolised droplets. The incubation period of pertussis is commonly 9–10
days, with a range of 6–20 days (1).

Pertussis is highly communicable. The secondary attack rate for susceptible household contacts is
80–100%. Untreated cases are infectious for three weeks following symptom onset. Antibiotics can
reduce the period of infectivity.

Reservoir
Pertussis is a human disease. No animal or insect source or vector is known to exist. There is no
evidence of prolonged carrier state. Asymptomatic individuals have been identied during epidemics.
Adolescents and adults are an important reservoir for B. pertussis and are signicant sources of
transmission of B. pertussis to unvaccinated infants.

Occurrence
Pertussis occurs worldwide. Outbreaks were rst described in the Sixteenth century. The disease is
endemic in all countries with epidemic peaks occurring every 2 to 5 years (typically 3 to 4 years), even
after the introduction of effective vaccination programmes and the achievement of high vaccination
coverage. Following introduction of vaccine in the 1940s the incidence of reported pertussis and
deaths in children have decreased. However, pertussis remains one of the principal VPDs even in
countries with high vaccine coverage (1).

Classical pertussis is most often seen in pre-school and school-aged children. It is an important cause
of death in infants worldwide. Pertussis may be responsible for between 12% and 32% of chronic
cough in adults.

Clinical features and complications

The illness begins less dramatically with non-specic symptoms and then progresses in the following
three stages:

Catarrhal: initially, patients develop catarrhal symptoms including cough. Other nonspecic
symptoms are rhinorrhoea, sore throat and conjunctivitis. This stage typically lasts two weeks. Fever is
present in less than 20% cases.

Paroxysmal: later, during the course of 1–2 weeks, coughing paroxysms occur, ending in
characteristic whooping. In typical cases, cough is frequently followed by vomiting. Paroxysms can

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occur more than 30 times in 24 hours and are more common at night. They occur spontaneously or are
precipitated by external stimuli such as noise and cold air. Between coughing episodes, there are few
clinical signs unless complications develop. This stage also typically lasts two weeks.

Convalescent: the coughing gradually subsides. Relapse can occur if another respiratory infection is
acquired. This stage can last from two weeks to several months.

Pertussis in infants, adults and partially immunized individuals may not present with its typical clinical
signs and symptoms.

Other common features of pertussis are:

• Infants:
Ø Apnoea
Ø Cough (no whoop)
Ø Cyanotic episodes
Ø Vomiting
Ø Poor feeding
Ø Fever
Ø Seizures
Ø Sudden infant death syndrome
• Partially immunized:
Ø Duration of catarrhal phase may be reduced
Ø Whoop may not occur
• Adults:
Ø Prolonged cough
Ø Paroxysmal cough
Ø Whoop
Ø Post-tussive vomiting
Ø Intracranial haemorrhage.

The most common complication is secondary bacterial pneumonia that causes most of pertussis-
related deaths. Neurological complications such as seizures and encephalopathy may occur as a result
of hypoxia from coughing, or possibly from toxin. Infants are at the highest risk for developing
pertussis-related complications.

Other less serious complications of pertussis include otitis media, anorexia and dehydration.
Complications resulting from pressure effects of severe paroxysms include pneumothorax, epistaxis,
subdural haematomas, hernias and rectal prolapse.

Prognosis
The infection gradually resolves over a period of weeks, but the coughing paroxysms can persist for
several months. Most of the older children and adults have a full recovery from pertussis; however,
infants need careful monitoring to avoid complications. The prognosis is worse when complications
such as bacterial pneumonia develop. Most deaths from pertussis have occurred in children who have

6
not been vaccinated or who are too young to have received the vaccine. In high mortality countries, CFR
is estimated to be 4% among infants and 1% among older children (4).

Neonatal tetanus
Tetanus, also known as lockjaw, is derived from the Greek word tetanos and teinein, which literally
means 'a stretching, tension', and 'to stretch' respectively. It is a serious but preventable disease that
affects the body’s muscles and nerves.

Aetiopathogenesis
Tetanus is an infectious bacterial disease caused by Clostridium tetani. C. tetani is a gram-positive,
strictly anaerobic bacillus that may develop a terminal spore, giving it a drumstick appearance. The
bacterium itself can survive only in strict anaerobic conditions, but its spores are much more resistant
and survive normal disinfection and heating. If a wound is contaminated with tetanus spores, they are
able to germinate, allowing bacterial multiplication.

The bacilli may produce tetanospasmin, an extremely potent neurotoxin. This toxin blocks inhibitory
neurotransmitters in the central nervous system and causes the muscular stiffness and spasms typical
of generalized tetanus (5).

Transmission and communicability

Maternal tetanus is a consequence of unclean delivery or abortion practices. Neonatal tetanus occurs
when unclean instruments are used to cut the umbilical cord or when contaminated material is used to
cover the umbilical stump in susceptible babies.

The incubation period of tetanus usually varies between 3 to 21 days (median 7 days, range 0–>60
days). In most cases, NT starts 3–14 days after birth (6).

Reservoir
Spores are prevalent in the environment, particularly in the soil of warm and moist areas and may be
carried in the intestinal tracts of humans and animals.

Occurrence
The majority of tetanus cases occur in developing countries and are birth associated, occurring among
newborn babies or in mothers following unclean deliveries and poor postnatal hygiene. Tetanus in
children and adults following injuries may also constitute a considerable public health problem.

In countries with effective immunization programmes and good standard of hygiene, maternal and
neonatal tetanus (MNT) has been largely eliminated (<1 case per 1000 live births at the district level).
On rare occasions, tetanus may affect inadequately immunized people, primarily among the elderly.

Clinical features and complications

In most cases, tetanus presents as a generalized spastic disease. Characteristic features are early
spasms of the facial muscles (trismus or “lock-jaw” and risus sardonicus) followed by spasm of the
back muscles (opisthotonos) and sudden, generalized tonic seizures (tetanospasms). Spasm of the
glottis may cause sudden death. In NT, generalized spasms are commonly preceded by inability to suck
or feed and excessive crying.
7
Prognosis
Neonatal tetanus is associated with a high mortality rate, despite intensive care. It can be prevented by
immunization of expectant mothers and by good hygiene and asepsis during delivery. A short incubation
period and low birth weight are associated with a high mortality rate and are poor prognostic factors. The
CFR for NT ranges from 40% in developed countries to 80% in the poorest developing countries.

The overall tetanus CFR varies between 10% and 70%, depending on treatment, age and general health
of the patient. Without hospitalization and intensive care, fatality is almost 100% among the oldest and
the youngest patients. In settings with optimal care, it may be reduced to 10–20% (7).

8
LABORATORY DIAGNOSIS
Laboratory diagnosis of suspected cases of diphtheria and pertussis disease is essential for
conrmation of cases and to guide the programme in the right direction. For VPD surveillance, efforts
should be made to establish laboratory diagnosis of all suspected cases of diphtheria and pertussis.
Conrmation of suspected cases of tetanus will be done only on a clinical basis and does not require
any laboratory diagnostic test.

Bacterial culture is considered to be the gold standard laboratory test for bacterial pathogens. The
specicity of culture for diphtheria and pertussis is considered 100%; however, in the antibiotic era,
the sensitivity of culture method for bacterial pathogens is pretty low, more so for pertussis because
it is a fastidious organism to grow. Further, its sensitivity decreases with use of antibiotics prior to
sample collection. Molecular tests (PCR) are gaining more importance because of increased
sensitivity and faster reporting of results. PCR does not require viable organisms and can detect
genes of dead bacteria, so results are not affected by prior use of antibiotics. PCR is however less
specic than culture.

Various serological methods have also been described but are not considered to be highly specic.
Serological test has also been described for diagnostic purposes, but its use is limited to the diagnosis
of pertussis cases during the convalescent phase.

Various laboratory tests available for establishing diagnosis of diphtheria and pertussis are
discussed below.

Diphtheria
Gram stain
Diagnosis of diphtheria based on direct microscopy of smear is not advisable as false positives and
false negatives may occur.

Culture
The clinical specimen for culture should be taken from the nose, throat or diphtheritic membrane.
C. diphtheriae requires special culture media containing tellurite to grow and forms grey to black
colonies. The four biotypes (gravis, mitis, belfanti, or intermedius) of C. diphtheriae can be
distinguished by colonial morphology and biotyping. Certain biochemical tests are required to
differentiate pathogenic C. diphtheriae from corynebacteria of the normal ora (diphtheroids) in the
throat.

Toxigenicity test
All isolates of C. diphtheriae should be subjected to toxigenicity testing to determine the production of
diphtheria toxin. Toxigenicity testing can be done by Elek test or PCR. Elek test is based on the double
diffusion of diphtheria toxin and antitoxin in an agar medium. The production of diphtheria toxin can be
detected within 18 to 48 hours by the formation of a toxin–antitoxin precipitin band in the agar.
Demonstration of toxin production conrms a case as diphtheria.

9
Polymerase chain reaction
Isolation of C. diphtheriae may not always be possible because many patients will have received
antibiotics before a diagnosis of diphtheria is considered. PCR allows for detection of the regulatory
gene for toxin production (dtxR) and the diphtheria toxin gene (tox) in nonviable organisms.
Additionally, primary isolates can also be screened rapidly for the presence of tox gene by PCR. Some
strains of C. diphtheriae carry inactive toxin gene giving rise to false positive results in this test.

Pertussis
Culture
Culture of nasopharyngeal secretions is considered best for diagnosis of pertussis. B. pertussis is
highly sensitive to drying; therefore, the specimen should be inoculated without delay onto the culture
media. Regan-Lowe agar or freshly prepared Bordet-Gengou medium is generally used for culture.
Fastidious growth requirement makes B. pertussis difcult to isolate.

Isolation of the organism declines if:

• specimen collection has been delayed beyond the rst two weeks of illness (catarrhal stage)
• patient has received appropriate antibiotic therapy
• patient has been vaccinated.

Since the maximum chances of isolating the organism are during the catarrhal phase, when the
aetiology of the infection is not suspected, there is only a small window of opportunity for culture
proven diagnosis.

Polymerase chain reaction

PCR is an important tool for timely diagnosis of pertussis. It detects deoxyribonucleic acid (DNA)
sequences of the bacterium and does not require presence of viable bacteria in the specimen. The optimal
sensitivity of the test is during the rst three weeks of cough, as bacterial DNA is present in the nasopharynx
during this time. After the fourth week of cough, the amount of bacterial DNA diminishes rapidly.

Serological testing
This can be a useful tool for diagnosis of pertussis in cases with more than four weeks of cough onset.
As serology conrmation is based on estimation of immunoglobulin G (IgG) titres, history of pertussis-
containing vaccine in past two years makes the serological testing an unreliable tool. In children over 10
years of age, serological conrmation could be used more condently (8). Enzyme immunoassay
detecting immunoglobulin A (IgA) and IgG antibodies to pertussis toxin, lamentous haemagglutinin,
pertactin and mbriae are gaining increasing importance as a diagnostic tool for B.pertussis.

Neonatal tetanus
There is no diagnostic laboratory test for tetanus; the diagnosis is entirely clinical. C. tetani is recovered
from wounds in only about 30% of cases, and the organism is sometimes isolated from patients who
do not have tetanus.

10
IMMUNIZATION AND
IMMUNE RESPONSE
Under the Universal Immunization Programme (UIP), the Government of India (GoI) currently provides
vaccination to prevent 12 VPDs across the country (nationally against ten diseases and sub-nationally
against two disease). These are tuberculosis (TB), polio, hepatitis B, diphtheria, pertussis, tetanus,
Haemophilus inuenzae type b (Hib), measles, rubella, rotavirus diarrhoea, pneumococcal
pneumonia and Japanese encephalitis (JE). In children <1-year old, diphtheria, tetanus, pertussis,
hepatitis B and Hib are provided as a combination vaccine called pentavalent vaccine. Children in the
age group of 1–7 years receive diphtheria, pertussis and tetanus vaccine in the form of DPT. In
addition, for adolescents and pregnant women, tetanus and diphtheria vaccine (Td) is given as a stand
alone vaccine.
Three doses of the pentavalent vaccine, starting at 6 weeks of age and given at least 4 weeks apart, are
recommended for primary immunization of infants. The primary vaccination series is extended by a
booster dose of DPT vaccine at 16–24 months of age. To further promote immunity, a second booster
of DPT vaccine has been recommended at 5–6 years of age.
Tetanus beyond the neonatal period is still a public health problem, particularly among children,
adolescents and young adults. Two additional doses of Td are recommended at 10 years and 16 years
of age. To address maternal and neonatal tetanus, immunization of all eligible pregnant women with two
doses of Td is recommended (one dose if previously vaccinated within three years).
The GoI has introduced JE vaccine for endemic districts while pneumococcal conjugate vaccine is
being introduced in a phased manner.
Table 1. Immunization schedule as per UIP in India
Vaccine & its
S.No Protection Route Dose(s) Vaccination schedule
presentation
1. BCG (Bacillus TB Intradermal 1 At birth (up to 1 year if
Calmette-Guérin) – not given earlier)
lyophilized vaccine
2. OPV Poliomyelitis Oral 5 Birth dose for institutional
Oral polio vaccine deliveries, primary three
(OPV) – liquid vaccine doses at 6, 10 & 14 weeks
and one booster dose at
16–24 months of age
3. Hepatitis B – liquid Hepatitis B Intramuscular 1 Birth dose (within 24
vaccine hours) for institutional
deliveries

4. Pentavalent – liquid Diphtheria, pertussis Intramuscular 3 At 6, 10 and 14 weeks

vaccine (wP), tetanus, of age
hepatitis B and Hib

5. Fractional inactivated Poliomyelitis Intradermal 2 At 6 and 14 weeks of age

polio vaccine (IPV) –
liquid vaccine
6. Rotavirus – liquid or Rotavirus Oral 3 At 6, 10 & 14 weeks
lyophilized vaccine of age

11
7. Pneumococcal Pneumococcal Intramuscular 3 At 6 and 14 weeks of age
conjugate vaccine – pneumonia, meningitis and booster at 9 months
liquid vaccine and other of age
complications

8. Measles–rubella (MR) Measles and rubella Subcutaneous 2 At 9–12 months of age

–lyophilized vaccine and second dose at
16–24 months

9. JE– lyophilized Japanese encephalitis Subcutaneous 2 At 9–12 months of age

vaccine and second dose at
16–24 months

10. DPT – liquid vaccine Diphtheria, pertussis Intramuscular 2 At 16–24 months and
(wP) and tetanus 5–6 years of age

11. Td – liquid vaccine Tetanus and diphtheria Intramuscular 2 At 10 years and 16 years
of age
2 For pregnant women, two
doses given (one dose if
previously vaccinated
within last 3 years)

OPV – oral polio vaccine; wP – whole-cell pertussis; IPV – inactivated polio vaccine; MR – measles–rubella; JE – Japanese encephalitis;
DPT – diphtheria, pertussis and tetanus; Td – tetanus–diphtheria

Components of DPT-containing vaccines (pentavalent, DPT, Td)

Diphtheria toxoid: a modied bacterial toxin that induces protective antitoxin. The conventional steps of
vaccine production include the growth of toxin-producing C. diphtheriae in liquid media, sterilization of
exotoxin-containing supernatant, formalin-induced conversion of toxin to toxoid, adsorption to
aluminium salt and addition of thiomersal as a preservative in multidose vials. The resulting product is
tested for potency, toxicity and sterility. As per WHO requirements, the potency of diphtheria vaccine
should be at least 30 IU per single human dose.

Tetanus toxoid: a modied neurotoxin that induces protective antitoxin. Conventional production includes
growth of toxigenic strains of C. tetani in a liquid medium that favours toxin production, toxin harvest by
ltration and detoxication by formaldehyde, followed by several steps of purication and sterilization. To
increase immunogenicity, the toxoid is adsorbed to aluminium or calcium salts. According to WHO, the
requirement for the potency of tetanus toxoid should be at least 40 IU per dose (0.5ml).

Whole-cell pertussis vaccine: whole-cell pertussis (wP) vaccine contains whole non-viable bacterial
cells in various amounts. Selected B. pertussis strains are cultured and then killed by heat and treated
with formalin to form the vaccine. The methods used for production vary among manufacturers and
hence wP vaccines are relatively heterogeneous. Each lot of vaccine undergoes extensive testing to
assess potency, toxicity, sterility and bacterial concentration. All pertussis vaccines contain aluminium
salts as adjuvant and thiomersal as preservative for multi-dose formulations.

12
Another formulation available commercially is aP vaccine. This is based on highly puried selected
components of the bacterial agent. The exact components and quantity of the antigens, method of
antigen production, purication and detoxication vary with the manufacturers. The aP vaccines
have lower initial efcacy, faster waning of immunity and possibly a reduced impact on
transmission relative to currently internationally available wP vaccines, but aP vaccines show less
local and systemic side-effects.

Immune response
The duration and level of protection following primary immunization by DPT-containing vaccines varies
considerably depending on factors such as local epidemiology, immunization schedule, choice of
vaccine and host factors. Immunity depends mainly on the presence of antibodies of IgG type.
Antibodies passed through the placenta provide passive immunity to the newborn during the rst few
months of life. The natural course of a disease is inuenced by the age-specic proportion of
susceptible and resistant persons in the community. Neither infection nor primary vaccination confers
long-lasting immunity to subsequent infection or disease. Multiple boosters are required for long term
protection against these diseases.

Following primary immunization, infants aged 6 weeks or older develop protective titres of antibodies
against the three diseases. A booster dose given during the second year of life improves protection and
prevents early accumulation of susceptible individuals. In countries that are rendered non-endemic
through high immunization coverage, revaccination of adults every 10 years with an age-appropriate
vaccine may be necessary to sustain immunity in some epidemiological settings.

In 1998, WHO recommended that TT be replaced by Td vaccine. This is reiterated in the 2017 WHO
tetanus vaccine position paper. The rationale for replacing TT with Td vaccine is the need to sustain
protection against diphtheria due to waning diphtheria immunity following the primary series of DPT-
containing vaccine given in the rst year of life. By replacing TT with Td, additional protection against
diphtheria can be obtained without major changes to the immunization programme and schedule.
When pregnant women receive the recommended doses of Td at least two weeks before delivery, both
mother and child are protected against birth-associated tetanus because maternal tetanus antitoxin
passes via the placenta to the foetus (9).

13
CASE SELECTION
A case denition denes a disease by a set of criteria to report suspected cases of that disease for
public health surveillance. It enables consistent reporting of cases by the reporting network and
improves specicity of reported cases.

Diphtheria
Suspected case denition
A suspected case of diphtheria is dened as an illness of the upper respiratory tract characterized by the
following:
• laryngitis or nasopharyngitis or pharyngitis or tonsillitis
and
• adherent membranes of tonsils, pharynx, larynx and/or nose (10).

Description of case denition

Pharyngitis and tonsillitis: fever with pain and redness of the throat and/or tonsils
Laryngitis: often presents as hoarseness of voice and cough
Nasopharyngitis: runny nose, nasal congestion and sneezing
Membrane: initially isolated spots of grey or white exudate appear in the tonsillar and pharyngeal area.
These spots often coalesce within a day to form a conuent sharply demarcated pseudo-membrane
that becomes progressively thicker, more tightly adherent to the underlying tissue and darker grey in
colour. Dislodging the membrane is likely to cause bleeding. Unlike the exudate in streptococcal
pharyngitis, the diphtheritic pseudo-membrane often extends beyond the margin of the tonsils onto the
tonsillar pillars, palate, or uvula.

Other associated signs and symptoms

The other clinical features that should raise an alarm for the probability of diphtheria infections are
dysphagia, difculty in breathing, headache, change of voice (hoarseness or thick speech), nasal
regurgitation and sero-sanguineous nasal discharge. Some patients may also present with “bull neck”
diphtheria where there is massive cervical lymphadenopathy with oedematous swelling of the
submandibular region and surrounding areas. Patients with diphtheria may also present with systemic
manifestations of diphtheria toxin like myocarditis and polyneuritis.

Date of onset
The date of onset for diphtheria should be considered as date of onset of sore throat, i.e. pain or
scratchy sensation in the throat that worsens with swallowing or talking.

Pertussis
Suspected case denition
A suspected case of pertussis is dened as a person of any age with a cough lasting ≥2 weeks, or of
any duration in an infant or any person in an outbreak setting without a more likely diagnosis and with at
least one of the following symptoms on observation or parental report:
• paroxysms (i.e. ts) of coughing

14
 • inspiratory whooping
• post-tussive vomiting, or vomiting without other apparent cause
• apnoea in infants (< 1 year of age)
or
• clinician suspicion of pertussis (8).

Description of case denition

Paroxysms of cough: cough becomes more frequent and spasmodic with repetitive bursts of ve to ten
coughs, often within a single expiration. During a paroxysm there may be a visible neck vein distension,
bulging eyes, tongue protrusion and cyanosis. Frequency of paroxysmal episodes varies from 5–10
per day to several per hour. Episodes are often worse at night and interfere with sleep.
Whoop: sound produced due to rapid inspiration against closed glottis at the end of a cough paroxysm.
Post-tussive vomiting: vomiting immediately after coughing occasionally with a mucous plug expelled
at the end of an episode.
Without other apparent causes: exclude other causes of chronic cough like TB, asthmatic episodes,
chronic bronchitis, etc.

Other associated signs and symptoms

In young infants, apnoea and cyanosis may be the only presenting symptoms. The clinical features due
to increased intra-thoracic pressure generated due to paroxysms of cough are frequently associated
with pertussis cases. These are subconjunctival and intracranial haemorrhages, rectal prolapse,
hernias, pneumothorax, petechiae or rib fracture.

Date of onset
The date of onset for pertussis should be considered as date of onset of cough.

Neonatal tetanus
Suspected case denition
A suspected case for NT is a case that meets either of these two criteria:
• any neonate who could suck and cry normally during the rst 2 days of life and who cannot
suck normally between 3 and 28 days of age, and becomes stiff or has convulsions/spasms,
i.e. jerking of the muscles or both
or
• any neonate who dies of an unknown cause during the rst month of life (11).

Description of case denition

Spasm: initially, increased tone of facial muscles (lockjaw, grimace) is seen. Inability to suck, stiffness
in the neck, shoulder and back muscles appear concurrently. Subsequent involvement of other
muscles produce rigid abdomen and stiff proximal limb muscle. These spasms occur repetitively and
may be spontaneous or provoked by even the slightest stimuli.

Date of onset
The date of onset for neonatal tetanus should be considered as date of onset of inability to suck.

All suspected cases of diphtheria, pertussis and neonatal tetanus having date of
onset within the past three months should be notied immediately to the programme.

15
CASE INVESTIGATION
Quality case investigations are critical for obtaining accurate epidemiological and clinical information
from cases. The details documented in the case investigation form (CIF) provide the basis of data
analysis and monitoring of indicators (Annex 1). Any suspected case of diphtheria, pertussis and/or NT
notied by the reporting system should be investigated as soon as possible, preferably within 48 hours.
An early investigation will provide opportunities for sample collection and timely intervention. For
example, medical aid provided early in the course of illness will reduce the morbidity and mortality from
the disease and prevent or decrease its transmission in the community.

A CIF has been designed for the investigation of suspected cases of diphtheria, pertussis and NT. The
CIF can be used as a guide to obtain all desirable and specic information of a suspected case.

Description of case investigation form

The initial sections of the CIF collect information on case reporting, identication, hospitalization and
immunization details.

Clinical signs and symptoms of the suspected case should be documented as “yes/no” in the CIF. As
the date of onset is critical information, it should be documented accurately in the CIF. Specically,
various performance and monitoring indicators are calculated from the date of onset, so it is extremely
important to specify the correct date of onset of illness.

The date of onset for the three diseases should be considered as follows:
• Diphtheria: date of onset of sore throat
• Pertussis: date of onset of cough
• Neonatal tetanus: date of onset of inability to suck.

The use of antibiotics and partial immunization may change the natural course and presentation of
diphtheria and pertussis illness. Therefore, efforts should be made to elicit a proper immunization
history and history of antibiotic use. In suspected diphtheria cases, timely administration of diphtheria
antitoxin (DAT) could be lifesaving.

The presence of greyish-white adherent membrane in the throat is pathognomonic of diphtheria. All
clinicians should be advised to proactively examine the throat under sufcient light to identify the
membrane in all cases presenting with fever and sore throat.

While pertussis presents primarily with classical symptoms in children aged 1–5 years, it may be
unrecognized in infants, older children, adolescents and adults because of atypical presentation. In
young infants, pertussis may cause apnoea and cyanosis without cough, whereas in adolescents and
adults an uncharacteristic persistent cough may be the only manifestation. As India is endemic for TB
and has a high disease incidence, it is important to exclude the diagnosis of TB in patients presenting
with chronic cough.

16
The duration of protection following primary immunization against diphtheria and pertussis varies
considerably. In view of the highly infectious nature of diphtheria and pertussis, information about similar
symptoms in household contacts/neighbourhood/school/workplace should also be actively elicited.

Additional cases of similar illness in the community help to identify clustering of cases. While
conducting active case searches (ACSs), the teams should look for such cases in all age groups.
Attempts should be made to conduct an ACS as soon as possible after the identication of a suspected
case, preferably within seven days of the case investigation. The details of conducting an ACS in the
community are described in the chapter on “Case management and public health interventions”. The
information on ACS in the community (form: VPD-ACS) should then be summarized in the CIF.

If the ACS is for pertussis, children presenting with onset of cough of less than two weeks duration
should be noted and followed by a local health worker (personal visit/telephonically) for persistence of
illness for more than two weeks after onset. All cases with persistent cough should be reported as
suspected cases of pertussis.

For all cases of diphtheria and pertussis, information on sample collection and laboratory conrmation
should be entered and updated in the CIF.

Each suspected case of diphtheria, pertussis, or NT should be classied as laboratory conrmed,

epidemiologically linked, clinically compatible, conrmed NT or rejected.

All cases of diphtheria, pertussis and NT should be followed up telephonically after 60 days from date
of onset and outcome of follow up should be entered in the CIF.

17
ASSIGNING A UNIQUE
IDENTIFICATION CODE
Assigning a unique identication code is an important way of assuring the quality of epidemiological
data. The unique identication code is important for generating a computerized line list of cases, as
personal identication information can be the same for two or more cases. Allotment of this code will
facilitate electronic merging of information collected in the eld with that generated in the laboratory.

The unique case identication code is a 16-character alphanumeric code allotted to each case of DPT.
The rst three characters are related to the suspected disease of the case; these are – DTH for
diphtheria, PTS for pertussis and NNT for NT. The remaining 13 characters determine time, place and
person identication. The rst eight characters dene the geographical location of the case by allotting
a unique identication code for country, state and district. The universally accepted country code for
India (IND) will be used here. To maintain uniformity and facilitate data analysis, it is mandatory to use
the pre-dened state and district codes which are annexed in this manual. The last ve characters of
case identication code will depict the year of onset and serial number of the case of a district.

For example, if Bulandshahar district of Uttar Pradesh is reporting the rst diphtheria case of 2019, the
identication code allotted will be DTH-IND-UP-BLS-19-001, where:

• DTH- Suspected diphtheria code

• IND – Country code

• UP – State code

• BLS – District code

• 19 – Year of onset

• 001 – Serial number of diphtheria case of the district in that year.

The identication code, once allotted to a case of VPD, should not be repeated for any other case. In
order to avoid re-allotment of the code, it should only be assigned by the District Immunization Ofcer
(DIO) or Surveillance Medical Ofcer (SMO) in coordination with each other.

18
SAMPLE COLLECTION AND
TRANSPORTATION
Laboratory conrmation of diphtheria and pertussis is considered the gold standard for case
classication of clinically suspected cases. Suspected cases of tetanus do not require any laboratory
test; the typical clinical presentation is considered pathognomonic. The recommended sample for
diphtheria and pertussis should be collected as early as possible during the course of illness of the
suspected cases. The chances of isolating the organism fall rapidly after 2–3 weeks of onset or by use
of appropriate antibiotics. The diphtheria and pertussis bacteria have fastidious growth requirements
and are susceptible to drying; therefore, the use of transport media is recommended to enhance
positivity of laboratory tests.

The prerequisites for sample collection and conditions of sample storage and transportation for
diphtheria and pertussis are described in Table 2.

Table 2: Prerequisites and conditions for sample collection

Prerequisites/conditions Diphtheria Pertussis*

Window period from onset Within 4 weeks Within 4 weeks Within 12 weeks
Type of specimen Throat swab or pieces of Nasopharyngeal Serum
membrane swab
Number 2 2 1

Transport media Amies transport media Regan-Lowe/Amies Not required for serum
transport media
with charcoal
O
Storage and transportation 2–8 C 2–8OC 2–8OC

* Within four weeks both nasopharyngeal swab and serum will be collected

Procedures for collecting samples

Throat swab sample collection
• Use any throat swab made of cotton, polyester or dacron
• Check the expiry date on the tube and transport media to ensure acceptability of the material
to be used for sample collection
• Label the Amies transport tube with the unique identication code, patient’s name and date of
collection
• Swab the inamed area of tonsils and posterior pharynx without touching any other parts of
the mouth. If membrane is visible, then rub the swab beneath the membrane
• Piece of membrane can also be collected on the swab
• Immediately place the throat swab sample in Amies transport media
• Immediately insert the swab till the bottom of the media

19
 • If capped swab, then throw the cap of the tube. If uncapped swab, then cut the shaft of the
swab to t into the tube and cap it securely
o
• Ship the sample to the laboratory at 2–8 C.

Nasopharyngeal swab sample collection

For identication of pertussis, it is mandatory to collect nasopharyngeal swab or aspirate. Throat swab
sample is not recommended for laboratory conrmation of pertussis.
• Obtain a thin exible nasopharyngeal swab made up of dacron or nylon. Cotton and calcium
alginate swabs are not to be used
• Check the expiry date on the tube and transport media to ensure acceptability of the material
to be used for sample collection
• Label the Amies transport tube with charcoal with the unique identication code, patient’s
name and date of collection
• Have the patient sit in the mother’s lap or with head against a wall or a support as patients
have a tendency to pull away during this procedure
• Explain the procedure to the parents or patient
• Measure the distance between anterior nares to the lower lobe of the ear of one side
• Mark the swab with half of the above measured distance
• Ask the patient to blow the nose forcefully to remove any mucous plug
• Position the head slightly upwards and insert the swab along the base of the nose up to the
distance marked. Avoid insertion of swab in upward direction
• Do not force swab if obstruction is encountered before reaching the nasopharynx. Remove
swab and try the other side
• Try to leave the swab in place for 5–10 seconds to increase sensitivity
• Immediately place the swab in Regan-Lowe transport media/Amies transport media with
charcoal and tighten the cap of specimen collection container
o
• Ship at 2–8 C.

Serum sample collection for serological diagnosis of pertussis cases

It is recommended that one serum sample should be obtained from pertussis suspected cases.
• Arrange the site for serum separation and obtain a serum collection kit before going for
sample collection
• Use of standard precautions is recommended when collecting any biological specimen
• Properly label a blood collection tube with name, identication code and collection date
• Using acceptable venepuncture technique, collect 2 to 3 ml whole blood
• Rest the tube undisturbed at room temperature for a minimum of 15 minutes to allow clot
to form
• After this, the tube can be transported at 4–8oC to the centrifugation site
• Centrifuge sample to separate serum from clot. This can also be accomplished by storing the
o
whole blood sample in an upright position overnight in the refrigerator (2–8 C)
• Properly label a 2 ml plastic storage tube in which serum is going to be collected
o
• Serum samples should be stored and transported at 2–8 C.

20
CASE CLASSIFICATION
Case classication is important to group a disease for apt use of resources in case management and
public health interventions. It also supports epidemiological analysis and exchange of information with
policy-makers, health ofcials and in providing feedback.

Case classication diphtheria and pertussis

Every reported case that has been investigated, irrespective of sample collection, should undergo case
classication as per Fig. 1.

Fig. 1: Algorithm of case classication of a suspected case of diphtheria and pertussis

Suspected case reported

Diphtheria/Pertussis

Case investigation

Typical signs & symptoms

Yes No

Sample

Yes No

Lab result

Epidemiological
Pos Neg linkages

Yes No

Laboratory Epidemiologically Clinically

Rejected
conrmed linked compatible

Laboratory conrmed
A case that meets the clinical case denition, where samples are collected and laboratory results are
positive for the suspected disease through culture and/or PCR.

Epidemiologically linked
Diphtheria: a case that meets the denition of a suspected case and is epidemiologically linked to a
laboratory conrmed case. In this situation, a person has had intimate respiratory or physical contact
with a laboratory-conrmed case within 14 days prior to onset of sore throat (10).

21
Pertussis: a case that meets the denition of a suspected case and is epidemiologically linked to a
laboratory conrmed case. In this situation, a person has had close contact with a laboratory-
conrmed case within three weeks prior to onset of cough (8).

Clinically compatible
A case that meets the suspected case denition but is neither laboratory conrmed nor
epidemiologically linked.

Rejected
A case that does not meet the suspected case denition on case investigation.

Laboratory conrmation of diphtheria and pertussis is important because other pathogens can cause
similar symptoms. A laboratory test can be negative even when the patient has these diseases. The
case classication helps to increase the sensitivity for detecting such cases when conrmatory
laboratory testing is not done or is negative.

Case classication neonatal tetanus

Conrmed neonatal tetanus
A conrmed case is any suspected NT case found during case investigation to have all three of the
following:
• normal ability to suck and cry during rst two days of life
and
• could not suck normally between 3 and 28 days of age
and
• developed muscle stiffness and/or spasms (jerking) (11).

Rejected
A case that has been investigated and does not satisfy the clinical criteria for conrmation, or has an
alternate diagnosis.

22
CASE MANAGEMENT AND PUBLIC
HEALTH INTERVENTIONS
To reduce morbidity and mortality of VPDs, detected cases must receive prompt and appropriate
medical care. Additionally, necessary public health interventions must be taken to restrict the
spread of the disease. The initiation of specic therapy during the early phase of clinical illness
tends to be more effective for rapid recovery of cases. As mortality rates are higher in younger age
groups and in unimmunized children, detection of even a single case of diphtheria and pertussis
should target identication of such high-risk groups and their protection by appropriate measures.
Case management and subsequent public health interventions following detection of DPTs are
discussed below.

Diphtheria: case management

The clinical outcome in diphtheria is improved by prompt initiation of specic therapy; therefore,
physicians should act on clinical suspicion after collecting appropriate specimens for laboratory
diagnosis. Although CFRs have reduced in developed countries, morbidity and mortality is still high in
many developing countries. Urgent treatment of diphtheria is mandatory to reduce complications and
mortality. Discovery of diphtheria antitoxin has revolutionized case management of diphtheria and
resulted in a reduction in CFR.

Diphtheria case management has the components described here.

Isolation
Respiratory droplet isolation of patients with respiratory diphtheria is required till antimicrobial therapy.
If facilities are not available for droplet isolation, screens should be placed between patients to limit
potential transmission and limit contact between the case and other patients in the health facility (10).

Collection of throat swabs for culture

Swabs should be taken as soon as possible after diphtheria is suspected, and treatment should not be
delayed while waiting for laboratory results.

Administration of diphtheria antitoxin

Intravenous or intramuscular administration of equine derived DAT (polyclonal IgG antibody) is highly
effective and is the gold standard for diphtheria treatment. Diphtheria toxin that has already entered the
host cells is unaffected by DAT. Therefore, to reduce complications and mortality, DAT should be
administered as soon as possible after disease onset, preferably intravenously in serious cases.

The entire therapeutic dose should be administered at one time. The amount of antitoxin recommended
varies between 20 000 to 100 000 units, with larger amounts recommended for persons with extensive
local lesions and with longer interval since onset. The dose is the same for children and adults (12).

Antibiotic therapy
Antibiotic therapy is recommended in case management of diphtheria. Antibiotics have no impact on
already established toxin-induced lesions but limit further bacterial growth and the duration of

23
corynebacterial carriage that often persists even after clinical recovery. Penicillin 0.6–1.2g 6-hourly, or
erythromycin 0.5g 6-hourly is recommended. Antibiotic therapy should be continued for 14 days.

Supportive measures
Supportive management of complications, with particular attention to the airway and cardiac
manifestations are an important part of case management. Patients should be nursed in strict isolation
and should be attended by staff with documented immunization histories.

Early in the illness, respiratory and cardiac complications are the greatest threat. These can be
minimized by close monitoring (including regular electrocardiogram [ECG]) and early Intervention (e.g.
pacing for conduction disturbances, drugs for arrhythmia). Some experts recommend tracheostomy
or intubation at an early stage to ensure continued patency of a compromised or potentially
compromised airway, and mechanical removal of any tracheobronchial membrane.

Immunization as needed during convalescence

Protective immunity does not always develop after recovery from disease. Therefore, individuals
recovering from diphtheria should complete the age-appropriate recommended course of diphtheria
toxoid vaccination during convalescence.

Pertussis: case management

Treatment is most effective in lessening symptoms if offered early in the disease during the rst 1–2
weeks before coughing paroxysms occur, but during this time pertussis is most difcult to diagnose.
Most previously immunized adults or adolescents recover even without antibiotics because of milder
illness than that seen in infants and young children.

Treatment in later stages is important to eliminate B. pertussis from the nasopharynx and prevent
transmission to more vulnerable populations. Treatment is recommended at any time within 3 weeks of
cough onset for those over 1 year of age, and within 6 weeks of cough onset for those less than 1 year
of age. The period of communicability is reduced to 5 days after treatment with antibiotics. Coughing
(symptomatic) household members of a pertussis patient should be treated as if they have pertussis.
Early treatment and prevention of transmission may reduce the considerable burden of adult pertussis:
loss of work, prolonged symptoms and multiple provider visits.

There are no proven treatments for pertussis-induced cough; steroids and beta-agonists are not
effective. Macrolide antibiotics eradicate B. pertussis within 5 days. Recommendations include
azithromycin (for 5 days) or clarithromycin (7 days). These have fewer gastrointestinal side effects,
easier dosing and better compliance than erythromycin (which is recommended for 14 days). In infants
<1 month of age, azithromycin is preferred due to concerns for infantile hypertrophic pyloric stenosis,
which is associated with erythromycin.

Trimethoprim/sulfamethoxazole for 14 days is an alternative for patients who cannot tolerate

macrolides and who are not pregnant, nursing, or <2 months of age.

No work or school is recommended for patients with suspected pertussis until completion of at least 5
days of antimicrobial therapy.

24
The primary DPT vaccine series is essential for reducing severe disease in young infants. Even one
dose of DPT may offer some protection against fatal pertussis disease in infants.

Immunity to pertussis from vaccine or disease wanes over time, and persons who have been
vaccinated or had prior infection can become infected. New data on the duration of protection from
acellular pertussis vaccines suggest that signicant waning of immunity occurs within 2–3 years of
vaccination, particularly in persons who never received any doses of whole cell vaccine.
Recommended treatment for pertussis is given in Table 3.

Table 3: Recommended treatment and post-exposure prophylaxis for pertussis, by age group (13)
Alternate agent:
Age group Azithromycin Erythromycin* Clarithromycin
TMP-SMX†
<1 month Recommended 40–50 mg/kg per Not recommended Contraindicated in
agent for infants day in 4 divided infants <2 months
<1 month of age; doses x 14 days of age (risk for
10 mg/kg per day in kernicterus)
a single dose x 5
days#
1–5 months 10 mg/kg per day in 40–50 mg/kg per 15 mg/kg per day Contraindicated in
a single dose x 5 day in 4 divided in 2 divided doses infants <2 months
days doses x 14 days x 7 days of age. For infants
aged >2 months of
age, TMP 8 mg/kg
per day; SMX 40
mg/kg per day in 2
divided doses x 14
days

Infants aged ≥6 10 mg/kg as a 40–50 mg/kg per 15 mg/kg per day TMP 8 mg/kg per
months and children single dose on Day day in 4 divided in 2 divided doses day; SMX 40 mg/kg
1 (maximum 500 doses x 14 days x 7 days per day in 2 divided
mg); then 5 mg/kg doses x 14 days
per day as a single
dose on Days 2–5
(maximum 250
mg/day)

Adolescents and 500 mg as a single 2g/day in 4 divided 1g/day in 2 divided TMP 320 mg/day,
adults dose on Day 1 then doses x 14 days doses x 7 days SMX 1600mg/day
250 mg as a single in 2 divided doses x
dose on Days 2–5 14 days
*Some experts prefer erythromycin estolate over erythromycin stearate or ethylsuccinate because it achieves higher serum levels with
equal doses.

†Trimethoprim-sulfamethoxazole (TMP-SMX) can be used as an alternative agent to macrolides in patients >2 months of age who are not
pregnant or nursing and are allergic to, cannot tolerate, or are infected with a rare macrolide-resistant strain of Bordetella pertussis.

#Preferred macrolide for this age because of risk of idiopathic hypertrophic pyloric stenosis associated with erythromycin

25
Neonatal tetanus: case management
The morbidity and mortality of tetanus patients admitted to the hospital decreased substantially in the 1960s
and 1970s with the advent of mechanical ventilation and the introduction of benzodiazepines with their high
efcacy and wide therapeutic index. Mortality rates of less than 20% are increasingly common for both
neonatal and non-NT patients, if they have the benets of care in a modern intensive care unit. Even in settings
with limited resources, if basic medication, experienced medical supervision and high-quality nursing can be
provided, mortality can be reduced to less than 50%. The greatest impediment to improved survival of tetanus
patients in developing countries is the lack of access to appropriate medical care. Therapeutic approaches
depend on the resources available in the facility to which the patient presents.

The specic objectives of tetanus treatment are to stop the production of toxin at the site of infection, with
appropriate wound care and antibiotic use; to neutralize circulating toxin with antitetanus immunoglobulin;
and to provide effective management of muscle spasm, respiratory failure, autonomic dysfunction and
complications that arise during the course of illness.

Antibiotics
Intravenous penicillin G (100 000–200 000 IU/kg/day, given in 2–4 divided doses) and metronidazole (7.5
mg/kg IV every 6–8 hours) are rst-line treatments in both maternal and NT cases.

Immunoglobulin
A single intramuscular dose of 500 units of human anti-tetanus immunoglobulin, also known as tetanus
immune globulin (TIG) is recommended as soon as possible to prevent further progression of the disease.
TIG can only help to remove unbound tetanus toxin. It cannot affect toxin bound to nerve endings. If TIG is
not available, equine-derived antitoxin tetanus serum (ATS) can be given in a single intravenous dose, after
testing for hypersensitivity. Alternatively, intravenous immunoglobulin (IVIG) may be used (5).

Symptom control and supportive care

In many developing countries, chlorpromazine and phenobarbitone (nasogastric or intravenous
administration) remain the mainstay of treatment for NT because they are affordable sedatives.

Intravenous diazepam is used widely in neonates and adults to control spasms. In the absence of
ventilator facilities, drugs such as intramuscular paraldehyde are used for further spasm control.

Active case search, contact tracing and management

Active case search and contact tracing in the community
ACS in response to identication of diphtheria and pertussis cases in the community is very important.
Occurrence of a diphtheria case in the community indicates gaps in routine immunization (RI) coverage
and build-up of a susceptible cohort. There is a very high probability of nding additional cases among
contacts of diphtheria and pertussis cases due to the high attack rate of these diseases. Besides
conducting ACSs in households and neighbourhoods, the workplace or school contacts should also be
actively assessed for these illnesses. A thorough ACS in the community will identify any clustering of
cases. Timely interventions have the potential to curtail the outbreaks and reduce case morbidity and
mortality.

26
How to conduct ACS and contact tracing
ACS should be conducted after proper microplanning and training of team members. All the
households of the village/tola/mohalla should be visited by the team. One auxiliary nurse midwife
(ANM)/staff can visit 50 households in a day. Households can be allotted to each team member, using
polio microplans. The team should mark house number/date on all the households visited. Logistics for
sample collection and shipment should be arranged beforehand. The ACS team should be trained on
VPD-ACS format, suspected case denition, how to identify close contact and identication of
unimmunized and under-immunized children/person(s).

While conducting ACS, the teams should be primed to look for cases in all age groups. VPD-ACS forms
(given at Annexure 2 and 3) are to be used to facilitate ACS in the community. This form will collate
information on demographic prole and summarize the number of suspected cases identied during
house-to-house searches. For a rapid assessment of pentavalent/DPT immunization status of the
community, the form also captures total doses of these vaccines received by the youngest child (under
15 years of age) in the household. Once a suspected case has been identied, detailed information
regarding the illness should be captured in the space provided in the form. Analysis of VPD-ACS forms
will help in selecting cases that require detailed investigation, i.e. lling of CIF and intervention by a MO.
A lab technician will collect specimens from suspected cases and will send them to the DIO/SMO ofce
under cold chain.

The summary information of ACS should be entered in the VPD-CIF (Annexure 1) under the section
“Active case search and response in community” for completeness of the information. Attempts should
be made to conduct ACS soon after identication of a suspected case and preferably within seven days
of case investigation.

Diphtheria
Management of contacts
Monitor close contacts for signs and symptoms for 10 days from the date of the last contact with a
suspected case. At a minimum, close contacts are considered to be household members and others
with a history of direct contact with a case. These may include caretakers, relatives, sexual contacts,
fellow students and friends who regularly visit the home. Medical staff exposed to the case’s oral or
respiratory secretions or exposed to their wound should also be monitored. Ideally, surveillance staff
should communicate daily with contacts to monitor for new symptoms, but the extent of monitoring is
determined by public health resources (10).

Prophylactic antibiotics (penicillin or erythromycin) are indicated for close contacts. The number of
contacts who received and completed their prophylactic antibiotics should be entered in VPD-ACS form.

Recommended post-exposure prophylaxis for diphtheria contacts is given in Table 4.

27
Table 4: Recommended post-exposure prophylaxis for diphtheria contacts
Age Immunization Prophylaxis
Antibiotic Dose Route Duration
<7 years old Penta/DPT Penicillin G 600 000 units IM Single dose
benzathine
or
Erythromycin 40 mg/kg in PO 7–10 days
4 divided doses
>7 years old Td Penicillin G 1.2 million units IM Single dose
benzathine
or

Erythromycin 1g/day in PO 7–10 days

4 divided doses
IM – intramuscular; PO – per oral
Note: Azithromycin (10 mg/kg body weight), a long acting oral antibiotic, is also being used as single daily dose for three days (14).

Diphtheria antitoxin is not recommended as post exposure prophylaxis (PEP) among contacts, as
evidence of its benet is limited.

Immunization of contacts
The contacts and susceptible cohort (un- and under-immunized) identied during ACS should be given
a dose of diphtheria-containing vaccine appropriate to their age. All children less than 7 years of age
should be immunized by a single dose of DPT if they have not received diphtheria-containing vaccine in
the previous ve years. Persons aged more than 7 years cannot be immunized with DPT vaccine that is
used in RI due to the adverse effects of pertussis component. Such individuals should be given Td
(tetanus with low dose diphtheria antigen) vaccine. The vaccination should be done through an
outreach session site in the village. In areas with poorly vaccinated population, in-school vaccination
can be planned. The number of susceptible persons receiving at least one dose of diphtheria-containing
vaccine should be entered in the VPD-ACS form.

Surveillance, investigation and response in outbreak settings

Denition of an outbreak: a single laboratory conrmed case of diphtheria should trigger a public
health response. Two temporally and geographically linked cases, of which at least one is laboratory
conrmed, is considered an outbreak of diphtheria (10).

Surveillance during an outbreak: during outbreaks, identify additional cases using clinical diagnosis
based on typical pseudomembranous pharyngitis without laboratory conrmation. However,
laboratory investigation of suspected cases is strongly recommended. Investigation of contacts might
reveal mild respiratory cases without psuedomembranes, these should be identied and counted as
laboratory conrmed or epidemiologically linked cases. Do not delay treatment pending laboratory
conrmation. All suspected cases should be line listed.

28
Public health response: conduct contact tracing, monitor for development of disease, collect
specimens, treat with antibiotics and vaccinate as described above.

Medical Ofcer in-Charge (MOIC) of health facility to send report of activities done on a daily basis and
then a nal report should be sent after the fteenth day of the start of outbreak response. The content of
the report should be as given in Table 5.

Table 5: Reporting format following public health interventions in diphtheria

Name of No. of No. of Number of No. of 0–7 No. of No. of No. of
village/tola/ households suspected contacts/ year-olds persons close persons
mohalla visited diphtheria susceptible received >7 years- contacts received
cases to be pentavalent/ old of index prophylactic
identied vaccinated DPT vaccine received case or antibiotics
Td vaccine suspected for
case diphtheria

Pertussis
Management of contacts
Contact investigation and management should focus on high-risk contacts at a minimum, and ideally
all close and high-risk contacts. Close contacts are people who have had face-to-face exposure to an
infected case, to include household or family contacts, people having stayed overnight in the same
room with a case and people having direct contact with respiratory, oral or nasal secretions of a lab-
conrmed case. High-risk contacts are not necessarily close contacts, but those that have been
exposed to a suspected case and are themselves at increased risk of complications from pertussis or
are at risk of transmitting the infection to other persons at risk of severe pertussis disease. These
include infants, pregnant women in the third trimester of pregnancy, health-care workers working with
infants or pregnant women and persons of any age working or sharing a house with infants (8).

Contacts should be tested only if they have symptoms consistent with pertussis infection.
Asymptomatic contacts of conrmed cases should not be tested, and testing of contacts should not be
used for post-exposure prophylaxis decisions.

Early treatment and post exposure prophylaxis: early treatment with macrolide antibiotics (such as
erythromycin and azithromycin) should be administered to close contacts who are infants <6 months
of age who develop symptoms of a respiratory infection.

Vaccination: under-vaccinated persons having contact with pertussis cases should be identied.
Pertussis-containing vaccine should be given to any person who is not fully immunized according to
the recommended immunization schedule. Vaccination might not prevent illness in a person who has
already been infected with B.pertussis.

Surveillance, investigation and response in outbreak settings

Denition of an outbreak: an outbreak is an increase in incidence or number of cases over the reported

29
baseline in a specic geographical area. Pertussis outbreaks can be difcult to identify and manage, given
the regular periodicity of pertussis and the existence of other respiratory pathogens causing similar
symptoms. Epidemiological outbreak investigations can provide useful information on vaccine
effectiveness and pertussis epidemiology, including the distribution of cases and CFR by age groups (8).

Specimens should be collected from ve cases to conrm the outbreak. After this point,
epidemiological linking should be done.

Public health response: during outbreaks, vaccination efforts should focus on the un- or under-
immunized. At the same time, RI in the outbreak area should be strengthened. Vaccination campaigns
are not part of pertussis outbreak response. Contact management is the same as mentioned above,
with a focus on early treatment among infants <6 months of age with signs of respiratory illness. While
antibiotics may prevent pertussis disease if given prior to symptom onset, there are no data to indicate
that widespread use of post-exposure prophylaxis (PEP) among contacts effectively controls or limits
the scope of community-wide pertussis outbreak.

Active screening for symptomatic patients with suspected pertussis should be done during outbreaks
in settings such as schools, day-care centres and hospitals.

Notify all public and private health facilities in the affected and nearby areas of the outbreak and inform
them to have a high index of suspicion for pertussis cases. Conduct health promotion activities and
distribute education materials to provide basic information about pertussis and its prevention,
particularly vaccination.

MOIC of health facility to send report of activities done on a daily basis and then a nal report should be
sent after the twentieth day of the start of outbreak response. The content of the report should be as
given in Table 6.

Table 6: Reporting format following public health intervention in pertussis

Name of No. of No. of Number of No. of No. of No. of No. of Remarks

village/ households suspected un- and children children close contacts
tola/ visited pertussis under- received received contacts received
mohalla cases immunized pentavalent DPT of index prophylactic
identied children vaccine vaccine case or antibiotics
suspected for
case pertussis

Neonatal tetanus
Contact tracing and management
As tetanus is not contagious, no contact tracing is needed.

Surveillance, investigation and response in outbreak setting

Tetanus is not considered an outbreak-prone disease. In general, NT outbreaks do not occur, but
clusters linked to a single source of substandard clinical care have been observed.

30
Public health response for neonatal tetanus
Vaccination: the mother of the suspected NT case should receive two doses of Td at an interval of 4
weeks.

Rapid community assessment

Starting from the house where the conrmed NT case occurred, move house-to-house to interview
10–15 other mothers in the community who delivered in the last two years about their vaccination
status, delivery place and attendant, application of substances to the umbilical cord, and the survival
and vaccination status of their last born child. The VPD-ACS NT form Annexure 3 should be used to
collect the information.

If at least 80% of mothers are protected (either through clean delivery and hygienic cord practices, or
protection at birth immunization status), the response will be limited to vaccination of the mother of the
NT case and promotion of clean birth and hygienic cord care practices.

If less than 80% of the mothers are protected, determine the cause of non-protection and formulate an
appropriate intervention. Include this area for outreach sessions and ensure vaccination of pregnant
women with tetanus toxoid-containing vaccine.

If less than 90% of the last born children received DPT3, strengthen RI services in the area (11).

Health education: provide information to the community and birth attendants about proper cord care. If
a source of unclean deliveries is identied, training and education may be provided to the birth attendant
to prevent further NT cases.

31
MONITORING AND SUPERVISION
Monitoring and supervision are important tools for establishing and maintaining efcient surveillance
and response systems. Monitoring and supervision are used to assess the quality of the surveillance
system over a time period against set norms and baseline data. The information should be used locally
to address and resolve problems related to control of diseases and strengthen the evolving programme.
Implementation of a surveillance system without a monitoring and supervision plan will result in no
improvements in the system, thus leading to increased risk of failure.

Monitoring refers to the routine and continuous tracking of the implementation of planned
surveillance activities. Evaluation is the periodic assessment of the relevance, effectiveness and
impact of surveillance activities. Monitoring data should be collected through the system itself by
the persons implementing the system with minimal resource implication. Evaluation ensures that
the surveillance system meets its objectives. It documents the status of performance or any change
in the system and provides an evidence base for any modication in the implementation strategies.
Evaluation of the surveillance system should be conducted periodically by external experts to have a
broader understanding of its functioning and bring a fresh perspective to the system. The inferences
and recommendations of monitoring and evaluation should be acted upon in a timely and
appropriate manner.

Supervision provides critical support for the delivery of health services. It serves numerous functions
like strengthening capacity of staff, ensures that the right skills are used appropriately, necessary
logistics are in place and that planned activities are implemented according to schedule. Supervisory
activities should be included in the work plan and the proportion of planned supervisory visits can be
documented to build condence in the system.

A detailed monitoring and supervision plan is being described here as an integral part of the VPD
surveillance implementation plan. The sources of information, methods and frequency of data
collection, monitoring indicators, data analysis and use of information are inbuilt in this plan.

Monitoring indicators
Indicators are variables that can be measured repeatedly over time and provide measures of change
in a system. They provide useful information on the status of the system and ag areas that need
improvement. A good indicator should have a precise denition of the numerator and denominator
that can be presented in a clear, concise and comprehensive way. The various monitoring indicators
recommended for DPT surveillance are discussed hereafter.

Proportion of cases with timely notication

This indicator is most crucial in determining the speed and quality of a surveillance system.
Timely notication of suspected cases has many advantages. Sample collection during the early
phase of disease increases the probability of laboratory conrmation, early detection of
impending outbreaks and case management. Timely public health interventions can reduce the
morbidity and mortality rates.

32
Diphtheria: the date of onset in suspected diphtheria cases should be considered as the day of
onset of sore throat. In most cases of diphtheria, a membrane appears in 2–4 days after onset,
and due to severity of symptoms, there is more likelihood that patients will seek early medical
care. The cases reported within seven days of disease onset should be considered as notied in
a timely manner.

Pertussis: the date of onset in suspected pertussis cases should be considered as the day of onset
of cough. Since the case denition of pertussis requires cough of more than two weeks duration and
paroxysms occur late (≥2weeks of cough onset) during the natural course of illness, early
notication of pertussis cases is not expected. The cases reported within four weeks of disease
onset should be considered as notied in time.

Neonatal tetanus: the date of onset in suspected NT cases should be considered as the day of onset
of inability to suck. The disease progression in neonates is very rapid, with high CFR early in the
course of illness; as such, cases reported within seven days of disease onset should be considered
as notied in time.
Total number of suspected diphtheria cases reported within 7 days of onset
Diphtheria = X 100
Total number of suspected diphtheria cases

Total number of suspected pertussis cases reported within 4 weeks of onset

Pertussis = X 100
Total number of suspected pertussis cases

Total number of suspected NT cases reported within 7 days of onset

Neonatal tetanus = X 100
Total number of suspected NT cases

A target of ≥80% should be achieved for timely notication. The reasons for delayed notication should
be analysed. These could be due to lack of awareness among health-care providers, lack of
understanding of reporting protocols, reporting network not tuned to pick early cases or
communication channels provided for notication are not free or updated. Appropriate actions to
achieve the target for this indicator will pay good dividends for classication of cases.

Proportion of cases with timely investigation

This indicator determines the alertness of the surveillance system to respond to notied cases. It is
expected that the assigned MO at block level should be able to investigate all notied cases in his block
within 48 hours of notication. It is calculated thus:

Total number of cases investigated within 48 hours of notication

X 100
Total number of reported cases

33
Efforts should be made to achieve a target of ≥80% for timely investigation. Clinical training of
assigned MOs at block level and tracking of cases after notication are important to achieve the target
for this indicator. This indicator should be analysed at the block level to identify the areas which should
be focussed on for active supervision.

Proportion of cases with adequate sample collection

This should be calculated disease-wise, as the sample collection in suspected cases of pertussis is
more challenging, and for suspected cases of tetanus no sample will be collected. It is calculated thus:

Total number of cases in which adequate sample is collected

X 100
Total number of suspected cases reported – total number of rejected cases

If disease is suspected, then appropriate laboratory testing should be done to conrm (or rule out) that
suspicion. If no testing is being done, it means that monitoring is inadequate or ineffective. Efforts should
be made to achieve the target of collecting samples in ≥80% suspected cases of diphtheria and pertussis.

If a large proportion of cases with no samples has been observed, the reasons could be multiple: late
notication of cases outside the window period of sample collection, health-care provider not condent
in sample collection procedure; lack of logistics; death; refusals and sample spoilt during storage and
shipment. Appropriate actions should be taken to achieve and maintain the target.

Proportion of rejected cases

This measures the proportion of reported cases that do not meet the clinical case denition of the
suspected disease. Disease-specic calculation and analysis of this indicator will be more useful. It is
calculated thus:

Total number of rejected cases

X 100
Total number of suspected cases reported

This indicator helps in understanding the level of awareness among health-care providers. The number
and type of reporting sites reporting such cases should be analysed, which helps to identify the training
needs of the reporting network. Sensitization visits should be planned accordingly to reduce the
proportion of rejected cases.

Proportion of timely ACS in the community

This indicator will help to monitor the preparedness of the government health system to build up a
community response. It should be calculated for diphtheria and pertussis separately. This indicator will
have little value in NT as it does not lead to outbreaks. The source of information to calculate this
indicator will be the CIF. It is calculated thus:

Total number of ACS conducted within seven days of case investigation

X 100
Total number of suspected cases

34
A target of at least 80% should be achieved for this indicator. Monitoring of this indicator will promote
timely ACS in the community and consequently, early identication of impending outbreaks. This
indicator will also help in identifying the areas of complacency or areas requiring support or resources
from the district level.

Timeliness of weekly reporting

This indicator determines the proportion of reporting units whose weekly reports are received on time
at the district. Weekly report in VPD-H002 form received by Tuesday afternoon is considered as timely.
Reports received after Tuesday afternoon but before next Monday are considered late, after which they
are considered as not received. This indicator is calculated thus:

Number of weekly reports received before Tuesday afternoon

X 100
Total number of reporting units

A target of ≥80% timeliness of weekly reporting should be achieved. Its periodic analysis will reveal
those reporting units that have failed to send the weekly report on time. This could have happened
because of gaps in the system, change of human resources, logistic issues, etc. This indicator is an
important tool to measure alertness of the reporting network.

Completeness of weekly reporting

This indicator determines the proportion of reporting units whose weekly reports have been received at
the district. It is calculated thus:

Number of weekly reports received

X 100
Total number of reporting units

The numerator includes all weekly reports received at the district before next Monday, irrespective of
their timeliness. Target of ≥90% completeness of weekly reporting should be achieved. The reporting
units not maintaining the completeness indicator of weekly reports should be brought to the notice of
district government ofcials for corrective action.

Data analysis
Ongoing analysis of surveillance data is important for detecting outbreaks, an unexpected increase or
decrease in disease occurrence, monitoring disease trends and evaluating the effectiveness of disease
control programmes and policies for identifying areas of improvement. Data analysis provides the
basis for taking action, targeting communities at risk or modifying programme strategies. This
information is critical to determine the most appropriate and efcient allocation of public health
resources and human resources.

35
Computer technology has greatly facilitated the collection and analysis of surveillance data. Analysis
should be performed at regular intervals using a standard approach. However, skilful interpretation of
data is needed to determine any aberrations and to develop a focussed action plan. Therefore, both
technology and human factors play important roles in the analysis of surveillance data.

Missing or inaccurate data may limit the usefulness of any analysis. Erroneous or incomplete data
cannot be corrected through statistical procedures.

Processes and interpretation

Analysis of surveillance data begins with characterizing the pattern of disease reports by person, place
and time. Knowledge of the specic pattern of disease occurrence in a geographical area is required to
identify changes in disease occurrence and disease prevention. This knowledge can be obtained only
through a continuous systematic process of consolidation and analysis of available surveillance data.

Time analysis: date of onset of symptom(s) is the most critical information which time analysis can be
based upon. Basic analysis by time can be conducted in several different ways to detect changes in
disease incidence, namely:
• comparing the number of cases occurring in the current week with the number in the
preceding four weeks
• comparing the number of cases during the current period (month, quarter) with the number
reported during the same period in previous years
• comparing the occurrence of disease by year to analyse long-term (secular) trends in a
disease
• clustering of cases over the specied period (weeks, months) should immediately raise an
alarm
• no cases during high transmission period should trigger an appropriate response for
verication of information.

Some diseases, e.g. pertussis naturally occur periodically as epidemic years followed by non-
epidemic years. An epidemic year will be followed by one or more years with relatively fewer number of
cases of the disease until another epidemic year occurs. Increasing immunization coverage changes
the epidemic pattern so that the time between epidemics increase.

Place analysis: the place where the case was residing at the time of onset of symptoms and during the
incubation period must be determined for all cases. We should analyse disease occurrence
simultaneously by time and place. Place analysis is best displayed by plotting the location of cases on a
local map over a specied period of time. Any spatial clustering of cases or silent areas will immediately
become visible to guide interventions. Repeated occurrence of cases in a particular geographical area
over many years helps in identifying high-risk areas for disease transmission.
A map of the number of cases by geographical area does not adjust for population densities. Similarly,
the number of cases in a specied geographical area over the past few years does not account for
growing population. Therefore, any analysis on disease occurrence should be based on calculation of
rates and not only on absolute number of cases occurring in a specied time and place.

36
Calculation of disease occurrence rate is done as follows:

Total no. of cases in one year in a specied geographical area

Disease
= X 100 000
occurrence rate Total population of specied geographical area

Analysis of disease occurrence rate will help in analysing disease trends over time and place and
identifying high-risk areas.

Person analysis: analysing surveillance data by characteristics of affected persons is also helpful. Age,
sex and religion are the most basic variables on which person epidemiology is studied. Other variables
such as vaccination status, hospitalization, associated risk factors for specic disease such as recent
travel or exposure in school or work place should also be looked into for targeted interventions.

Active supervision
Supervision is a critical part of human resource management to ensure optimum functioning of the
surveillance system. Supervision is the process of “directing and supporting staff so that they may
effectively perform their duties’’.

Through supervision, the health staff are supported and guided by their supervisor(s) to help them
perform better, and to ensure that planned activities are broadly on target. Supervision of the
surveillance staff at different levels of surveillance provides opportunities for informal training, support
and qualitative monitoring.

Supervision in health programmes traditionally used an inspection and control approach that is controlling
the worker’s adherence to policies and procedures. Health workers often receive little guidance or
mentoring on how to improve their performance. The major aw in traditional supervision is in its fault-
nding approach rather than on problem solving to improve performance. However, active supervision
should be a very participatory process that encourages effective two-way communication.

Supportive supervision has been used to promote sustainable and efcient programme management
by strengthening relationships within the system.

Making supervision more effective

Advance planning
Prepare a plan for regular supervisory visits to health facilities: When supervisory visits are made
routinely, supervisors are better able to monitor performance and can identify and address
problems before a negative impact on the programme. Poorer performing health facilities should
receive more visits.

Preparation for supervisory visits: Prepare updates, follow up recommendations of previous visits and
feedback specic to the health facility.

37
Stick to the schedule and respect the time of the health facility: Plan to spend sufcient time to conduct
supervisory visit.

Assess performance
Observe and note strengths and weaknesses together with the staff being supervised. Use information
gathered during the visit to discuss progress with the health facility team and make adjustments
as needed.
• Always ask for additional feedback
• Perform and document ACS in the facility by checking admission/OPD/emergency/ discharge
registers for any unreported case
• Verify data from reports that have been sent to the district by the facility and also ensure
quality of these reports
• Look for proper documentation of surveillance activities like case notication, investigation,
follow up and results.

Discuss ndings and strengthen capacity

• Always start by presenting the health staff and facilities’ positive attributes – “praise in
public, correct in private”
• Provide staff with informational updates and new recommended practices
• Give constructive feedback: Facilitate staff to identify areas of strengths and weakness and
help them to develop strategies for solving issues
• Discuss, listen and identify information/training needs together with the staff
• Develop a team approach to increase supportive supervision at a health facility and make it a
routine procedure with or without frequent visits from central or district level. Health facility
staff can develop supervision plans that t their structures and conduct regular self-
assessments to monitor their performance.

Dissemination of surveillance data

Dissemination of surveillance data to those who need to know is a critical component of the
surveillance system. The phrase “information for action” implies that a surveillance system should be
functionally linked with the public health programme. Clear communication and active dissemination of
evidence to all relevant audiences in easy to understand formats are critical to generate awareness and
for use of evidence.

Two types of audiences are benetted by surveillance information: (i) those who are involved in
operations of surveillance like health facilities, MOs, laboratory directors, etc.; and (ii) those who need
to know for administrative, programme planning and decision-making purposes. Surveillance
information should be disseminated in the most interpretable, persuasive and actionable manner. Clear
graphical presentations tend to be more appealing and easily understood than detailed tables.

Surveillance information serves two primary purposes – information and motivation. Information on
occurrence of the disease by time, place and person in the community informs local health providers

38
about the probability of their encountering the specic disease among their patients. A surveillance
report can also be a strong motivational factor. It demonstrates that the programme managers actually
look at the reported cases and surveillance data to take appropriate action. Such efforts are important
in maintaining a spirit of collaboration among the public health and medical communities which in turn
improves reporting to the surveillance system.

39
REPORTING NETWORK AND
CASE NOTIFICATION
Efcient and reliable reporting network and notication systems are vital for any disease surveillance.
In many developing countries, the number of cases that are reported into the system are under-
estimated for two main reasons:
• Community level: not all cases seek health care at the designated reporting sites (under-
ascertainment)
• Health facility level: failure of a reporting site to adequately report suspected cases that have
sought medical advice (underreporting). Common reasons for underreporting include lack
of knowledge, lack of appreciation of its importance, lack of motivation, competing priorities
and complexity of reporting procedures.

It is difcult to address under-ascertainment; however, underreporting can be addressed by diligently

selecting the reporting sites, creating awareness of the importance of case reporting, and regular
monitoring to verify the quality and completeness of reporting. The following criteria should be
considered for selecting a health facility for VPD surveillance:
• the health facility is willing to participate in surveillance activities
• the health facility serves a relatively large population of interest
• the health facility has medical staff sufciently specialized to diagnose, treat and report
cases of the diseases under surveillance.

A widely accepted reporting system along with a convenient reporting mechanism is essential for
effective surveillance of vaccine preventable diseases.

Structure
As part of the polio eradication initiative, a highly efcient surveillance system for AFP is already
functional in the country with the support of WHO India National Public Health Surveillance
Project (NPSP). Many of the weaknesses of a reporting network such as inadequate health
facilities, poor awareness, superstitions and beliefs that discourage reporting, conscious or
unconscious suppression of reporting have already been addressed in the AFP surveillance
system. Thus, it is prudent to base the VPD surveillance activities through the already
established AFP reporting network.

As the reporting of AFP cases does not require specialized medical skills, and to achieve the polio
eradication goal, the AFP reporting network was expanded to include non-specialized community level
health providers. Since reporting of suspected cases of diphtheria, pertussis and NT requires good
clinical skills, the whole of the AFP reporting network cannot be adopted for DPT surveillance. If the
non-specialized health providers are targeted for DPT reporting then it is expected that a huge number
of non-specic illnesses of fever, sore throat and cough might be reported to the system. Non-specic
reporting will be resource intensive and may unnecessarily burden the surveillance system.

40
The reporting network for DPT surveillance will consist of those AFP reporting sites that are
government health facilities, and health facilities with personnel having medical skills to identify
suspected cases of diphtheria, pertussis and NT.

The categorization of reporting sites as reporting unit (RU) and informer unit (IU) will remain the same
as in the AFP surveillance system.

Reporting units
These include large government or private health facilities. Usually, these facilities have both outpatient
and inpatient departments such as medical colleges, district hospitals, government health facilities and
big private hospitals.

The reporting units (RUs) usually maintain documentation of all patients attending that facility. All RUs
are required to send weekly reports to the district even when there are no cases of VPDs. Each RU
already has a designated AFP surveillance nodal MO (nodal ofcer) who can be motivated to support
the VPD surveillance activities.

Informer units
Informer units (IUs) are often smaller health facilities or clinics that are likely to see cases of VPDs.
These facilities usually do not maintain detailed documentation of the patients visiting them, or have
certain inhibitions in sending weekly reports. They notify the concerned ofcial whenever they come
across a case of VPD. They are not bound to send weekly reports.

Functions
Case notication
DPT surveillance is active surveillance of suspected cases of diphtheria, pertussis and NT. District
health ofcials (DIO/SMO) actively solicit information or reports on VPDs directly from the reporting
network. The reporting procedure is kept simple, as in the AFP surveillance system. Any reporting site
should immediately notify a suspected case of VPD by any available mode of communication to the
concerned ofcial or ofce. The minimum information required to notify a case is suspected VPD,
patient identiers and contact details.

Weekly reports
All reporting units should notify the district of all VPD cases detected in a week through a mechanism of
weekly reporting. The RUs are expected to submit their weekly repor ts in the form VPD-H002 to the
DIO/SMO ofce every Monday. The district then compiles this information in form VPD-D001 and
sends to the state every Tuesday. The state then collates information from VPD-D001 from all districts,
prepares a state report in form VPD-S001 and sends to the national headquarters every Wednesday.
The signed hard copies of the weekly reports or scanned copies are accepted as conrmation
of reporting.

The weekly report contains basic information along with the contact details of notiable cases during
the previous week. When no cases are seen in a week, a weekly report is still required specifying that
zero cases were seen. This is called “zero reporting” or “nil reporting”. Nil reporting gives condence

41
that the surveillance system is operational even if no disease is identied. This mechanism of
submitting weekly reports ensures completeness of the reporting system and translates into an
important monitoring indicator of performance of reporting sites. The timeliness of weekly reports can
also be monitored to identify any complacency in the system. Informer units are not expected to send
weekly reports.

The forms used to compile and send weekly reports are:

Form VPD-H003/003A: It is important to seek and collect information about notiable cases seen by
individual clinicians or departments in an RU. This information is documented in this form by the nodal
ofcer of that RU. It is desirable to obtain signatures of all concerned clinicians in this form for
authentication of the weekly reports.

Form VPD-H002: This is the weekly reporting form which should be sent every Monday. The
information contained in form VPD-H003/003A should be compiled to generate weekly reports.

Flow of weekly report is given in Fig. 2.

Fig. 2: Flow of weekly report

India HQ

State Wednesday
S001

District Tuesday
D002

RU Monday
H002

42
Collaboration and sensitization of health facilities
The awareness and skills of the health staff of health facilities included in the reporting network is a
major contributor to ensuring a sensitive, high quality surveillance system. Increased awareness
results in timely notication and investigation of suspected cases. Lack of knowledge regarding the
components of notication (what, when, how and to whom to report) is the most common cause of
under-reporting. Therefore, sincere efforts should be made to engage health staff of the selected health
facilities in surveillance activities.

There are various methods to encourage involvement and to increase awareness among health-care
providers of government and private sectors.

Introductory meeting
It is always useful to conduct an introductory meeting with the clinicians, hospital staff and health
workers. The goal of this meeting is to improve knowledge about the disease and to explain the rationale
for conducting surveillance. Standard case denitions, including all components of reporting a
suspected case of VPD, should be introduced. It should be emphasized that all cases that t the case
denition should be reported, irrespective of diagnosis.

Regular visits
During regular visits to the reporting sites, it is preferable to rst contact the nodal ofcer and take a brief
account of activities and concerns regarding VPD surveillance. Any knowledge or communication gap,
reluctance in reporting, poor accessibility and other barriers to active reporting should be appropriately
addressed. Such visits should also be utilized to meet with the institution/department head, MOs and
nursing staff of relevant departments. These visits should be used to build interpersonal relationships
to achieve maximum cooperation from the reporting sites.

Feedback
Feedback is an important mechanism to obtain continued involvement and commitment of the
reporting network. It can be a strong motivational factor for the reporting network, because it
acknowledges their contribution and demonstrates that the information they submitted is analysed for
action. It also improves the accuracy and promptness of reports. The feedback can be of three types:

General feedback: This includes summary information or updates on the epidemiology of the disease,
any revisions in the recommendations for vaccination or control strategies, etc.

Specic feedback: These are laboratory results, nal classication and updated information of the
reported cases. The reason for any delayed or missed reporting by a reporting site should be politely
addressed.

Urgent feedback: This is the conrmation of an outbreak or an individual case.

Feedback mechanisms can be improved if inferences and specic action points produced from
in-depth data analysis are communicated. Graphical presentations tend to be more appealing and
easily understood.

43
Sensitization workshops
These are an effective method of generating awareness among a group of health staff. This method can
generate awareness throughout the reporting network within a short time span. Conducting frequent
and quality sensitization workshops has the potential to give immediate impetus to improve the
notication rate. Different medical platforms like the Indian Medical Association (IMA), the Indian
Academy of Paediatrics (IAP), related conferences and monthly meetings of the government sector
should be targeted to organize such workshops. All reporting sites should be sensitized through such
workshops at least once in a year.

The quality of sensitization workshops depends largely on the training material and communication
skills of the trainer. Since most of the target audience of these workshops will be medical specialists,
the DIO and SMO should prepare and equip themselves with the latest information to be effective.

The training material should contain information about the current epidemiology of VPDs and rationale
for surveillance. The operational components of notication and reporting should be clearly explained
to prevent under-reporting. To increase the likelihood of timely reporting and specimen collection,
particular attention should be paid to explaining case denitions, procedures for specimen collection
and reporting formats.

44
ROLES AND RESPONSIBILITIES
VPD surveillance is useful both for measuring the need and effects of public health interventions by
Ministry of Health and Family Welfare with support from allied Ministries such as Women and Child
Development, Finance etc. Ofcials who decide to use public health surveillance as a management tool
must recognize that they will need to commit political support and human and nancial resources. For
successful implementation of a surveillance system, roles and responsibilities need to be xed, starting
from the grass-root level health workers to the top managers at state and union levels.

Implementing authority
The quality and timeliness of surveillance operations is of prime importance to the effective
functioning of disease surveillance. Since disease surveillance is an essential function of a public
health system, its implementation becomes the responsibility of government health ofcials.
District health ofcials (Chief Medical Ofcer [CMO]/DIO) need to take ownership of the programme
by ensuring that cases of diphtheria, pertussis and NT are reported in time and responded to
appropriately. Considering the population prole of districts in India and other administrative
responsibilities of district health ofcials, a block-level MO should be designated and trained to
carry out various activities related to VPD surveillance.

Roles and responsibilities of designated block level MO

Case investigation: All cases notied to the district should be properly investigated at the block level
using the standard CIF. A detailed case investigation will reveal information about the case meeting the
criteria of standard case denitions. All cases that do not meet the criteria of standard case denitions
should be rejected, with proper reason and documentation on the CIF. The cases that meet the criteria of
standard case denitions should be assigned a unique identication code in consultation with the
concerned district ofcial.

Sample collection and shipment: Appropriate sample collection as per the disease syndrome and
window period of sample collection should be done. The block level MO is responsible for arranging all
logistics for quality sample collection and shipment to the designated laboratory. Sample collection kits
for throat swab, nasopharyngeal swab and serum can be obtained from the district headquarters.
Efforts should be made to collect the samples before initiation of antibiotic therapy.

Case management: The block MO has to ensure proper treatment of the cases as per the
recommended guidelines. This can be best done through the reporting health facility by advising or
capacity-building of health ofcials working in that facility. Treatment should be initiated at the earliest
even in the absence of laboratory conrmation.

Sensitization efforts: For maintaining a sensitive system of disease surveillance, it is vital that the
designated block level MO actively participates in sensitization of the reporting network in various
ways. He or she should proactively pay sensitization visits to health facilities, especially facilities
missing out on cases or those that are performing poorly due to other reasons. Other mechanisms
such as sending text messages, phone calls or publishing newsletters to generate awareness can also
be used for sensitization efforts.

45
Providing feedback: The designated block level MO should ensure that the feedback on case results is
communicated to the reporting health facility and the case patient. Any unusual observation such as
increase in disease occurrence, clustering, deaths, etc. should be immediately brought to the notice of
the district health ofcials.

Technical advice and capacity building

Just as decision-makers require a competent, motivated economist to guide on budgetary planning
and allocations, they also need a competent technical advisory body to provide scientically valid
surveillance analysis and communicate the result as information for action. WHO India (NPSP) will
support the use of internationally gained experience in implementation and the operational translation
of ideas into action. NPSP will play an important role in:
• dissemination of information and technical advice
• capacity-building of surveillance staff and reporting network
• creating a sense of urgency in taking actions for better translation of information from report
to implementation
• advocacy for raising key technical aspects higher on the health agenda in the public and
private sectors
• exercising quality standards and embedding M&E in the implementation process.

NPSP will support a qualitative leap towards establishing and maintaining a disease surveillance
system that provides a scientic and factual database essential to inform decision-making and
appropriate public health actions.

Monitoring and evaluation

A structured approach of programme monitoring and evaluation function will strengthen the evolving
surveillance system. Monitoring and evaluation generates valuable information that should be used
locally to resolve problems. The district level unit ofces of NPSP will proactively support their
government counterparts in surveillance system performance assessment by implementing the
monitoring and evaluation plan described in this eld guide. Ongoing, systematic analysis of
monitoring indicators will provide useful information on the status of the implementation of the VPD
surveillance system and ag areas that need improvement.

Public health interventions and system strengthening

Completion of successful interventions determine the worth and effectiveness of the VPD surveillance
system. Collection and analysis should not be allowed to consume resources if action does not follow.
The key step for ensuring accountability and sustainability of the VPD surveillance system is to
institutionalize the response and supportive supervision mechanism within the government system
and other stakeholders. The District Task Force (DTF) meeting for immunization headed by the CMO
under the chairmanship of the District Magistrate should adopt a systematic approach towards
interventions and supportive supervision. Senior level managers of government and other prominent
institutions/organizations/professional bodies should be involved to help in decision-making and
system strengthening. The members of the district task force should be held accountable for their
specic roles and responsibilities.

46
Roles and responsibilities of District Task Force for Immunization for VPD surveillance
• Take appropriate public health interventions in response to identication of cases or
outbreaks
• Ensure involvement of the private sector in the surveillance activities, with special emphasis
on quality
• Take immediate and appropriate actions based on the ndings of monitoring and evaluation
of the VPD surveillance system

47
ANNEXURES
Annex 1: Case Investigation Form

48
49
 Annex 2: VPD-ACS DTH/PTS Form

50
 Annex 3: VPD-ACS NT Form

PHC/Planning Unit

51
Annex 4: Diphtheria antitoxin (DAT) administration*

Route
The IV route is the preferred route of administration of DAT, especially in severe cases. The antitoxin
dose should be mixed in 250–500 mL of normal saline and administered slowly over 2–4 hours,
closely monitoring for anaphylaxis. The antitoxin may be given IM in mild or moderate cases.
Temperature
Antitoxin should be warmed to 32–34°C (90–95°F) before injection. Warming above the recommended
temperature should be carefully avoided because the DAT proteins will denature.
Dosage
A. Perform sensitivity tests, and desensitization if necessary.
B. Give the entire treatment dose of antitoxin IV (or IM) in a single administration (except for
series of injections needed for desensitization).
C. The recommended DAT treatment dosage ranges are:
Pediatric and adult DAT dose

Diphtheria clinical presentation DAT dose (units)

Pharyngeal or laryngeal disease of 2 days duration 20 000–40 000

Nasopharyngeal disease 40 000–60 000

Extensive disease of 3 or more days duration, or any patient with diffuse swelling of neck 80 000–100 000

Skin lesions only (rare case where treatment is indicated) 20 000–40 000

D. Give children the same dose as adults.

E. Repeated doses of DAT after an appropriate initial dose are not recommended and may
increase the risk of adverse reactions.
Appropriate antimicrobial agents in full therapeutic dosages should be started immediately upon
suspicion of respiratory diphtheria (and ideally after specimen collection). For cutaneous diphtheria,
antitoxin is rarely required; attention should focus on wound hygiene and antimicrobial agent treatment.
The antibiotic of choice for treatment of cutaneous diphtheria is erythromycin or penicillin.
Any person with clinical symptoms of diphtheria should receive DAT as soon as it can be made
available, without waiting for bacteriologic conrmation of the diagnosis. Supportive treatment should
be continued until all local and general symptoms are controlled.
*Expanded Access Investigational New Drug (IND) Application Protocol: Use of Diphtheria Antitoxin (DAT) for suspected Diphtheria
Cases, Version Number 7.0. Atlanta: Centers for Disease Control and Prevention; 2016
(https://www.cdc.gov/diphtheria/downloads/protocol.pdf, accessed 26 August 2019).

52
Annex 5: Surveillance forms

53
54
55
56
 DPT

1
2

1
2

57
Annex 6: Supportive Supervision Form – VPD Surveillance
Name of supervisor Name of district
Facility reviewed Block

Awareness of case denition and reporting protocol

• Number of health staff interviewed –

• Number of health staff aware of case denition and reporting protocol –
• Overall impression of awareness – Good / Satisfactory / Needs improvement / Alarming
• Recommendations and follow up plans –

Assessment of records

• Number of unreported VPD case found –

• Status of documentation –
• Overall impression of record maintenance – Good / Satisfactory / Needs improvement / Alarming
• Recommendations and follow up plans –

Availability of logistics

• Availability of logistics of sample collection –

• Availability of surveillance forms –
• Recommendations and follow up plans –

Quality of case investigation

• Quality and completeness of CIF (if possible visit a case to verify details) –
• Overall impression of case investigation – Good / Satisfactory / Needs improvement / Alarming
• Recommendations and follow up plans –

Additional information

58
Annex 7: VPD surveillance during the COVID-19 pandemic
The COVID-19 pandemic is challenging health systems across the world. Rapidly increasing demand
for care of people with COVID-19 is compounded by fear, misinformation and restrictions on
movement of people and supplies that may disrupt the health care delivery. When health systems are
overwhelmed and people fail to access needed services, both direct and indirect mortality from
vaccine preventable diseases are likely to increase. Hence, VPD surveillance should be reinforced to
enable early detection, outbreak response and management of VPD cases.

Health services including immunization are deemed as essential and need to be functional across the
th
country, as per Ministry of Home Affairs (MHA) order dated 15 April 2020. Depending upon the
COVID-19 situation, areas are categorized as:
• Containment Zone: Areas where COVID-19 cases are reported
• Buffer Zone: Areas surrounding Containment Zone
• Area beyond Buffer Zone: Outside the Buffer Zone

Buffer Zone

Perimeter

Cluster of cases

Containment
Zone
Area beyond
buffer zone

The categorization of ‘Containment Zone’ and ‘Buffer Zone’ is a dynamic process based on active
COVID-19 cases and is updated regularly.

Basic principles for delivery of services in the context of COVID-19 outbreak:

1. Guidelines from MHA and MoHFW pertaining to COVID-19 and related updates will be the
primary reference points and no state should violate any COVID-19 guidance.
2. Practices of social distancing, hand washing, and respiratory hygiene need to be followed at
all levels.

59
This guidance addresses specic aspects of conducting VPD surveillance activities, while also
ensuring safety of health personnel in the context of COVID-19 and outlines basic principles and
practical recommendations for the same.

• Desk review of surveillance data: is an important tool to monitor the ongoing activities and
should be regularly carried out to provide feedback to the authorities during district weekly review
meetings. Data reviews should drive actions such as increase in telephonic active case searches
(ACS), feedback and directives to Medical Ofcer In-charges (MOIC). Key indicators for the review
should include tracking of case investigation, agging of outbreak and investigation, sample
collection including adequacy, discard rate, weekly comparison of number of suspected cases
and health facility contact analysis. Feedback from activities undertaken for quality assurance of
case investigation form (CIF) and sample collection should be included. Monthly surveillance
indicators and feedback on identied issues should be shared with district ofcials through
WhatsApp/email.
• Directive from District administration to blocks: Relevant district authorities should send written
communication (letter/email/WhatsApp) to blocks/health facilities to maintain surveillance and
response to AFP, measles, rubella, diphtheria, pertussis and neonatal tetanus (NNT) cases while
ensuring appropriate infection prevention and control measures as per MOHFW guidelines.

Table 7. Guidance on Key Surveillance Activities in COVID-19 Dened Zones

Activity Containment & Buffer Zone Areas beyond Buffer Zone

1. Sensitization of reporting sites Telephonic contact and other Active surveillance visits in all
virtual platforms priority reporting sites
2. Surveillance workshops Utilize virtual platform or small Utilize virtual platform or small
batches batches
3. Case notication & tracking P P
4. Case investigation by MOs PPE Kits and other measures P
5. Sample collection PPE kits and other measures P
6. Sample shipment P P

7. House to house searches Limited with PPE kits and other P

measures

Following standard guidelines of COVID-19 like social distancing, mask, PPE use in containment zone

1.1 Sensitization of reporting sites by Surveillance Medical Ofcer/District Immunization

Ofcer/Nodal Ofcer
• Active Case Searches (ACS)
} In areas beyond Buffer Zone: ACS as per existing guidelines
} In Containment and Buffer Zones: telephonic ACS and other virtual platforms.
Frequency of telephonic ACS will be as per routine norms

60
 • Block wise reporting sites (RS) may be allocated to different staff for ACS to avoid
duplication.
• DIO ofce/Administrative Assistant (AA) from WHO NPSP unit may conduct telephonic ACS
in the low priority reporting sites while Health staff/Field Monitor /Immunization Field
Volunteer (IFV), where applicable will conduct the ACS by visiting the low priority reporting
sites (LPs), unqualied practitioners and potential informers. In areas with travel restrictions,
Health staff/AAs/FMs/IFVs will ensure sensitization through telephonic ACS. The telephonic
ACS thus conducted should be documented in the in D-004/modied D-003 and at the same
time they should also track sample collection and shipment.

Surveillance workshops:
Workshops should be done using online video conferencing applications available at block level
through personal computers/smart phones. Avoid physical gathering of large number of participants
within a conned room. If unavoidable, then plan in small batches, ensuring physical distancing
measures. Thermal screening of participants should be carried out before they enter the training venue,
and any febrile person or having COVID-19 like symptoms should not attend the training.

1.2 Case notication/tracking register:

The register should be maintained at health facility for regular tracking of cases and thus identify
reasons for delay in case investigation, sample collection, sample shipment from eld to District
Immunization Ofcer (DIO)/Surveillance Medical Ofcer (SMO) ofce and shipment from ofce
to laboratory.

1.3 Case investigation by Medical Ofcers:

• In areas beyond buffer zone: standard IPC measures (wearing of triple layer mask/N-95
mask* and gloves) should be followed as per the available guidelines.
• In Containment and Buffer Zones: use PPE kits and other IPC measures should be followed
o NOTE: any medical staff having symptoms consistent with COVID-19 should not
participate in case investigation, sample collection and transportation.
o Any case suspected to have COVID-19 should be encouraged to wear a mask.

1.4 Sample collection and transportation:

• In areas beyond Buffer Zone: standard IPC measures should be followed as per the
available guidelines.

• In Containment and Buffer Zone: use PPE kits and other IPC measures should be followed.
• If transport is not available for shipment to district, it can be stored at the block level health
facility either in sample carrier (daily change of icepack should be done) or in a freezer if
available. Serum can be stored at 4-8°C for a maximum period of 7 days, beyond which it
must be frozen at -20°C and subsequently should be transported to the designated
laboratory. Repeated freezing and thawing should be avoided as it has detrimental effect on
the stability of IgM antibodies. Use standard IPC measures including wearing triple layer
medical mask and gloves along with hand hygiene measures.

61
1.5 Conducting house to house case searches
• In area beyond Buffer Zone: standard IPC measures should be followed as per the available
guidelines. House to house case searches, including during outbreak investigations should
be conducted with IPC measures, including physical distancing and hand and respiratory
hygiene. Interview should be conducted outdoors or in a well-ventilated space
• In Containment and Buffer Zone: limited house to house searches. Use of PPE kits and other
IPC measures should be followed.

1.6 Protecting self through infection prevention and control (IPC) measures
Physical distancing, hand and respiratory hygiene and the use of appropriate personal protective
equipment (PPE) according to a risk assessment.
• Avoid touching any surface (e.g. door handle, handrails, etc.) in the hospital. If any surface is
touched, immediately sanitize hands using alcohol-based hand rub.
• Wear gloves when touching blood, body uids, secretions, excretions, mucous membrane
or skin. Immediately perform hand hygiene in case of any such contact.
• Preferably do not sit anywhere within the hospital – standing is a much better option.
• Follow the Guidelines on Rational Use of Personal Protective Equipment issued by
Directorate General of Health Services [Emergency Medical Relief], Govt. of India

Table 8: Recommended PPE while doing VPD surveillance

S. No. Setting Recommended PPE Remarks

1. Telephonic interview of No PPE required
suspected/conrmed cases
2. In-person interview of Triple layer mask Physical distancing; hand
suspect/ conrmed cases White coat (full-sleeved) hygiene Interview to be done
outdoors Patient to wear triple
layer mask
3. Non-COVID eld activities, like Triple layer mask Physical distancing; hand
case investigations, hygiene; Respiratory hygiene/
concurrent monitoring etc. Cough etiquette
Interview/examination to be
done outdoors (if possible)
4. Handling of clinical samples – Triple layer mask Hand hygiene after handling of
stool, blood, serum, swab Gloves specimen

62
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